A randomised trial of "Fresh Start" text messaging to improve return to care in people living with HIV who missed appointments in South Africa.

OBJECTIVE: Treatment interruptions are a barrier to successful antiretroviral therapy (ART). "Fresh start messages", which leverage significant days on the calendar (e.g., new year, public holiday) in order to prompt action, have the potential to encourage people living with HIV to return to care. We evaluated a "fresh start" intervention (text messages) to increase return to care in PLHIV who had missed their last appointment. DESIGN: A three arm 1:1:1 individual randomised controlled trial. METHODS: We randomized adults in Capricorn District who had missed ART appointments by more than 28 days to: a) no text message; b) unframed messages (fresh start not mentioned); or c) framed messages (fresh start mentioned). Randomisation was stratified by treatment interruption duration and across two holidays (Youth Day, Mandela Day). The primary outcome was an ART-related clinic visit at ≤45 days of the first message. RESULTS: 9143 participants were randomised. For Youth Day, 1474 and 1468 were sent unframed and framed messages respectively, with 13.4% sent these messages having an ART visit vs 11.9% not sent a message (aOR 1.2; 95% CI:1.0-1.4, p-value = 0.075). For Mandela Day, 1336 and 1334 were sent unframed and framed messages respectively, with 6.7% sent these messages having an ART-related clinic visit vs 5.4% not sent a message (aOR 1.2; 95% CI: 1.0-1.6; p-value = 0.100). CONCLUSIONS: Low-cost text messages sent around a "fresh start" date may increase the likelihood that patients who miss appointments return to care. This study suggests the potential of text messaging for motivating return to care.

"Emotional stress is more detrimental than the virus itself": A qualitative study to understand HIV testing and pre-exposure prophylaxis (PrEP) use among internal migrant men in South Africa.

INTRODUCTION: South Africa has one of the highest rates of internal migration on the continent, largely comprised of men seeking labour in urban centres. South African men who move within the country (internal migrants) are at higher risk than non-migrant men of acquiring HIV yet are less likely to test or use pre-exposure prophylaxis (PrEP). However, little is known about the mechanisms that link internal migration and challenges engaging in HIV services. METHODS: We recruited 30 internal migrant men (born outside Gauteng Province) during August 2022 for in-depth qualitative interviews at two sites in Johannesburg (Gauteng) where migrants may gather, a factories workplace and a homeless shelter. Interviewers used open-ended questions, based in the Theory of Triadic Influence, to explore experiences and challenges with HIV testing and/or PrEP. A mixed deductive inductive content analytic approach was used to review data and explain why participants may or may not use these services. RESULTS: Migrant men come to Johannesburg to find work, but unreliable income, daily stress and time constraints limit their availability to seek health services. While awareness of HIV testing is high, the fear of a positive diagnosis often overshadows the benefits. In addition, many men lack knowledge about the opportunity for PrEP should they test negative, though they express interest in the medication after learning about it. Additionally, these men struggle with adjusting to urban life, lack of social support and fear of potential stigma. Finally, the necessity to prioritize work combined with long wait times at clinics further restricts their access to HIV services. Despite these challenges, Johannesburg also presents opportunities for HIV services for migrant men, such as greater anonymity and availability of HIV information and services in the city as compared to their rural homes of origin. CONCLUSIONS: Bringing HIV services to migrant men at community sites may ease the burden of accessing these services. Including PrEP counselling and services alongside HIV testing may further encourage men to test, particularly if integrated into counselling for livelihood and coping strategies, as well as support for navigating health services in Johannesburg.

Migrant men and HIV care engagement in Johannesburg, South Africa.

BACKGROUND: South Africa (SA) has one of the highest rates of migration on the continent, largely comprised of men seeking labor opportunities in urban centers. Migrant men are at risk for challenges engaging in HIV care. However, rates of HIV and patterns of healthcare engagement among migrant men in urban Johannesburg are poorly understood. METHODS: We analyzed data from 150 adult men (≥ 18 years) recruited in 10/2020-11/2020 at one of five sites in Johannesburg, Gauteng Province, SA where migrants typically gather for work, shelter, transit, or leisure: a factory, building materials store, homeless shelter, taxi rank, and public park. Participants were surveyed to assess migration factors (e.g., birth location, residency status), self-reported HIV status, and use and knowledge of HIV and general health services. Proportions were calculated with descriptive statistics. Associations between migration factors and health outcomes were examined with Fisher exact tests and logistic regression models. Internal migrants, who travel within the country, were defined as South African men born outside Gauteng Province. International migrants were defined as men born outside SA. RESULTS: Two fifths (60/150, 40%) of participants were internal migrants and one fifth (33/150, 22%) were international migrants. More internal migrants reported living with HIV than non-migrants (20% vs 6%, p = 0.042), though in a multi-variate analysis controlling for age, being an internal migrant was not a significant predictor of self-reported HIV positive status. Over 90% all participants had undergone an HIV test in their lifetime. Less than 20% of all participants had heard of pre-exposure prophylaxis (PrEP), with only 12% international migrants having familiarity with PrEP. Over twice as many individuals without permanent residency or citizenship reported "never visiting a health facility," as compared to citizens/permanent residents (28.6% vs. 10.6%, p = 0.073). CONCLUSIONS: Our study revealed a high proportion of migrants within our community-based sample of men and demonstrated a need for HIV and other healthcare services that effectively reach migrants in Johannesburg. Future research is warranted to further disaggregate this heterogenous population by different dimensions of mobility and to understand how to design HIV programs in ways that will address migrants' challenges.

Evaluation of four interventions using behavioural economics insights to increase demand for voluntary medical male circumcision in South Africa through the MoyaApp: A quasi-experimental study.

Background: While voluntary medical male circumcision (VMMC) reduces the risk of HIV transmission by 60%, circumcision coverage falls short of the UNAIDS 90% target. We investigated whether behaviourally informed message framing increased demand for VMMC. Setting: Adult users of the MoyaApp, a data free application in South Africa, who viewed a form designed to generate interest in VMMC during August-November 2022. Methods: A quasi-experimental study was conducted to evaluate four MoyaApp VMMC intervention forms against the Standard of Care (SOC) form. All forms enabled users to provide contact details for follow-up engagement by a call centre. The primary outcome was the proportion of forms submitted. Secondary outcomes included successful contact with the user, VMMC bookings/referrals and confirmed circumcision. Multivariable ordinary least-squares regression was used for the analysis. Results: MoyaApp VMMC form viewers totalled 118,337 of which 6% submitted a form. Foot-in-the-Door form viewers were more likely (+1.3 percentage points, p<0.01) to submit a form compared to the SOC group (6.3%). Active Choice (-1.1 percentage points, p<0.01) and Reserved for You (-0.05 percentage points, p<0.05) form viewers were less likely to submit a form compared to SOC. Users submitting on Foot-in-the-Door were less likely to be booked/referred compared to SOC (-5 percentage points, p<0.05). There were no differences between the intervention and SOC forms for successful contact and circumcisions. Conclusions: Message framing using behavioural insights was able to nudge men to engage with VMMC services. However, more work is needed to understand how to convert initial interest into bookings and circumcisions. Trial registration: South African Clinical Trials Registry DOH-27-062022-7811Pan-African Clinical Trials Registry PACTR202112699416418.

Understanding school-going adolescent's preferences for accessing HIV and contraceptive care: findings from a discrete choice experiment among learners in Gauteng, South Africa.

BACKGROUND: Many Adolescents in Sub-Saharan Africa do not access HIV and reproductive health services optimally. To improve uptake of these services, it is important to understand the Learners' preferences for how services are delivered so that implementation strategies can reflect this. METHODS: A discrete choice experiment (DCE) was used to elicit preferences. The DCE was completed between 07/2018 and 09/2019 and conducted in 10 high schools situated in neighbourhoods of varying socio-economic status (SES) in Gauteng (South Africa). Learners aged ≥ 15 years (Grades 9-12) were consented and enrolled in the DCE. Parental consent and assent were required if < 18 years old. Conditional logistic regression was used to determine preferred attributes for HIV and contraceptive service delivery. Results were stratified by gender and neighbourhood SES quintile (1 = Lowest SES; 5 = Highest SES). RESULTS: 805 Learners were enrolled (67% female; 66% 15-17 years; 51% in grades 9-10). 54% of Learners in quintile 1 schools had no monthly income (family support, grants, part-time jobs etc.); 38% in quintile 5 schools had access to R100 ($7.55) per month. Preferences for accessing HIV and contraceptive services were similar for male and female Learners. Learners strongly preferred services provided by friendly, non-judgmental staff (Odds ratio 1.63; 95% Confidence Interval: 1.55-1.72) where confidentiality was ensured (1.33; 1.26-1.40). They preferred services offered after school (1.14; 1.04-1.25) with value-added services like free Wi-Fi (1.19; 1.07-1.32), food (1.23; 1.11-1.37) and youth-only waiting areas (1.18; 1.07-1.32). Learners did not have a specific location preference, but preferred not to receive services within the community (0.82; 0.74-0.91) or school (0.88; 0.80-0.96). Costs to access services were a deterrent for most Learners irrespective of school neighbourhood; female Learners were deterred by costs ≥$3.85 (0.79; 0.70-0.91); males by costs ≥ R100 ($7.55) (0.86; 0.74-1.00). CONCLUSIONS: Preferences that encourage utilisation of services do not significantly differ by gender or school neighbourhood SES. Staff attitude and confidentiality are key issues affecting Learners' decisions to access HIV and contraceptive services. Addressing how healthcare providers respond to young people seeking sexual and reproductive health services is critical for improving adolescents' uptake of these services.

Applying behavioural economics principles to increase demand for free HIV testing services at private doctor-led clinics in Johannesburg, South Africa: A randomised controlled trial.

Background: Expanding free HIV testing service (HTS) access to include private clinics could increase testing rates. A donor funded programme, GP Care Cell, offered free HIV testing at selected private doctor-led clinics but uptake was low. We investigated whether HTS demand creation materials that used behavioural economics principles could increase demand for HIV testing at these clinics. Methods: We conducted a randomised controlled trial in Johannesburg, South Africa (January-April 2022) distributing brochures promoting HTS to adults in five private doctor-led clinic catchment areas. Individuals were randomised to receive three brochure types: (1) "Standard of care" (SOC) advertising a free HIV test and ART; (2) "Healthy lifestyle screening" promoted free low-cost health screenings in addition to HTS; and (3) "Recipient of care voucher" leveraged loss aversion and the endowment effect by highlighting the monetary value of free HTS. The primary outcome was presenting at the clinic following exposure to the brochures. Logistic regression compared outcomes between arms. Results: Of the 12,129 brochures distributed, 658 were excluded because of errors or duplicates and 11,471 were analysed. About 59% of brochure recipients were male and 50,3% were aged 25-34 years. In total, 448 (3.9%) brochure recipients presented at the private doctor-led clinics of which 50.7% were males. There were no significant differences in clinic presentation between the healthy lifestyle screening and SOC arm (Adjusted Odds Ratio [AOR] 1.02; 95% CI 0.79-1.32), and similarly between the recipient of care voucher and SOC arm (AOR 1.08; 95% CI 0.84-1.39). Individuals were more likely to attend clinics that were centrally located with visible branding for HTS (AOR=5.30; 95% CI: 4.14-6.79). Conclusion: Brochures that used behavioural insights did not increase demand for HTS at private doctor-led clinics. However, consistent distribution of the brochures may have potential to increase HIV testing uptake at highly visible private doctor-led clinics.

Costs and outcomes of routine HIV oral pre-exposure prophylaxis implementation across different service delivery models and key populations in South Africa.

Background: Oral pre-exposure prophylaxis (PrEP) is a highly efficacious biomedical HIV prevention tool, yet despite being recommended by the World Health Organization (WHO) since 2015, uptake and persistence remain limited in much of the world, including sub Saharan Africa (SSA). There is a dearth of evidence-based interventions to improve PrEP uptake and persistence in SSA, and the full costs of PrEP programs implemented in routine care settings remain largely unknown. This study aimed to evaluate the cost of delivery of daily oral PrEP, and associated outcomes, to different key and priority populations across different service delivery models (SDMs) in South Africa. Methods: We conducted bottom-up micro-costing of PrEP service delivery from the provider perspective within twelve urban SDMs providing routine PrEP services to various key and propriety populations in Gauteng and KwaZulu-Natal provinces in South Africa. The SDMs included in-facility and outreach models that focused on men who have sex with men (MSM), female sex workers (FSW) and adolescent girls and young women (AGYW). We identified all within- and above-facility activities supporting PrEP delivery, obtained input costs from program budgets, expenditure records and staff interviews, and determined individual resource usage between February 2019 and February 2020 through retrospective medical record review. Our primary outcome was PrEP coverage at six months (defined as having sufficient PrEP drug dispensed at the last visit to be covered at six months post PrEP-initiation). A subset (N=633) of all enrolled subjects had the potential for 12 months of follow-up and were included in a 12-month outcome analysis. We report the cost per client initiated on PrEP in 2021 United States Dollars (USD). Findings: We collected medical record data from 1,281 people who initiated PrEP at 12 SDMs between February and August 2019 and had at least six months of potential follow-up. The average number of visits was 2.3 for in-facility models and 1.5 for outreach models and 3,086 months of PrEP was dispensed. PrEP coverage at six months varied greatly across SDMs, from 41.8% at one MSM-focused fixed clinic to 0% in an MSM-focused outreach model. In general, in-facility programs had higher six-month coverage than outreach programs. Across all SDMs with PrEP clients with potential for 12 months of follow-up (n=633), PrEP coverage at 12 months was 13.6%, with variability between SDMs. The average six-month cost per client initiated on PrEP ranged from $29 to $590, with higher average costs generally observed for the in-facility programs ($152 in-facility versus $84 for outreach). The average monthly cost per PrEP client who had six-month PrEP coverage ranged from $18 to $160 dependent on SDM. Interpretation: This study is an important addition to the PrEP outcome and cost literature in the SSA region. Results show that costs and outcomes vary considerably across different SDMs and populations in real world PrEP programs and provide crucial information for further scale-up of the oral PrEP program in South Africa and the greater SSA region.

Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial.

INTRODUCTION: Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and more likely to have longer cycles of disengagement from ART programmes. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will test the impact of various interventions on 6-month retention in ART programmes among men living with HIV who are not currently engaged in care (never initiated ART and ART clients with treatment interruption). METHODS AND ANALYSIS: We will conduct a programmatic, individually randomised, non-blinded, controlled trial. 'Non-engaged' men will be randomised 1:1:1 to either a low-intensity, high-intensity or stepped arm. The low-intensity intervention includes one-time male-specific counseling+facility navigation only. The high-intensity intervention offers immediate outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. In the stepped arm, intervention activities build in intensity over time for those who do not re-engage in care with the following steps: (1) one-time male-specific counselling+facility navigation→(2) ongoing male mentorship+facility navigation→(3) outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. The primary analysis will be intention to treat with all eligible men in the denominator and all men retained in care at 6 months in the numerator. The proportions achieving the primary outcome will be compared with a risk ratio, corresponding 95% CI and p value computed using binomial regression accounting for clustering at facility level. ETHICS AND DISSEMINATION: The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums and in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors. TRIAL REGISTRATION NUMBER: NCT05137210. DATE AND VERSION: 5 May 2023; version 3.

A modelling framework for translating discrete choice experiment results into cost-effectiveness estimates: an application to designing tailored and scalable HIV and contraceptive services for adolescents in Gauteng, South Africa.

INTRODUCTION: South African youth and adolescents face a high burden of (Sexually Transmitted Infections) STIs, HIV and unintended pregnancies, but uptake of services remains low. To address this, tailored and scalable interventions are urgently needed. We developed a framework to fill the gap and translate the impact of facility-level attributes into a cost-effectiveness analysis for increasing HIV/contraceptive service uptake in adolescents using a discrete choice experiment (DCE). METHODS: We used a DCE (n = 805) conducted in Gauteng, South Africa, which found that staff attitude, confidentiality, Wi-Fi, subsidized food, afternoon hours and youth-only services were preferred attributes of health services. Based on this, we simulated the uptake of services adapted for these preferences. We divided preferences into modifiable attributes that could readily be adapted (e.g. Wi-Fi), and challenging to modify (more nuanced attributes that are more challenging to cost and evaluate): staff attitude and estimated the incremental change in the uptake of services using adapted services. Costs for modifiable preferences were estimated using data from two clinics in South Africa (2019 US$). We determined the incremental cost-effectiveness ratio (ICER) for additional adolescents using services of 15 intervention combinations, and report the results of interventions on the cost-effectiveness frontier. RESULTS: Greatest projected impact on uptake was from friendly and confidential services, both of which were considered challenging to modify (18.5% 95% CI: 13.0%-24.0%; 8.4% 95% CI: 3.0%-14.0%, respectively). Modifiable factors on their own resulted in only small increases in expected uptake. (Food: 2.3% 95% CI: 4.0%-9.00%; Wi-Fi: 3.0% 95% CI: -4.0% to 10.0%; Youth-only services: 0.3% 95% CI: -6.0% to 7.0%; Afternoon services: 0.8% 95% CI: -6.0% to 7.0%). The order of interventions on the cost-effectiveness frontier are Wi-Fi and youth-only services (ICER US$7.01-US$9.78 per additional adolescent utilizing HIV and contraceptive services), Wi-Fi, youth-only services and food (ICER US$9.32-US$10.45), followed by Wi-Fi, youth-only services and extended afternoon hours (ICER US$14.46-US$43.63). CONCLUSIONS: Combining DCE results and costing analyses within a modelling framework provides an innovative way to inform decisions on effective resource utilization. Modifiable preferences, such as Wi-Fi provision, youth-only services and subsidized food, have the potential to cost-effectively increase the proportion of adolescents accessing HIV and contraceptive services.

Strategies to improve antiretroviral therapy (ART) initiation and early engagement among men in sub-Saharan Africa: A scoping review of interventions in the era of universal treatment.

OBJECTIVES: Men in sub-Saharan Africa (SSA) have lower rates of antiretroviral therapy (ART) initiation and higher rates of early default than women. Little is known about effective interventions to improve men's outcomes. We conducted a scoping review of interventions aimed to increase ART initiation and/or early retention among men in SSA since universal treatment policies were implemented. METHODS: Three databases, HIV conference databases and grey literature were searched for studies published between January 2016 to May 2021 that reported on initiation and/or early retention among men. Eligibility criteria included: participants in SSA, data collected after universal treatment policies were implemented (2016-2021), quantitative data on ART initiation and/or early retention for males, general male population (not exclusively focused on key populations), intervention study (report outcomes for at least one non-standard service delivery strategy), and written in English. RESULTS: Of the 4351 sources retrieved, 15 (reporting on 16 interventions) met inclusion criteria. Of the 16 interventions, only two (2/16, 13%) exclusively focused on men. Five (5/16, 31%) were randomised control trials (RCT), one (1/16, 6%) was a retrospective cohort study, and 10 (10/16, 63%) did not have comparison groups. Thirteen (13/16, 81%) interventions measured ART initiation and six (6/16, 37%) measured early retention. Outcome definitions and time frames varied greatly, with seven (7/16, 44%) not specifying time frames at all. Five types of interventions were represented: optimising ART services at health facilities, community-based ART services, outreach support (such as reminders and facility escort), counselling and/or peer support, and conditional incentives. Across all intervention types, ART initiation rates ranged from 27% to 97% and early retention from 47% to 95%. CONCLUSIONS: Despite years of data of men's suboptimal ART outcomes, there is little high-quality evidence on interventions to increase men's ART initiation or early retention in SSA. Additional randomised or quasi-experimental studies are urgently needed.

A cost description of the setup costs of community-owned maternity waiting homes in rural Zambia.

Maternity waiting homes (MWHs) are one strategy to improve access to skilled obstetric care in low resource settings such as Zambia. The Maternity Homes Access in Zambia project built 10 MWHs at rural health centers in Zambia for women awaiting delivery and postnatal care (PNC) visits. The objective of this paper is to summarize the costs associated with setup of 10 MWHs, including infrastructure, furnishing, stakeholder engagement, and activities to build the capacity of local communities to govern MWHs. We do not present operational costs after setup was complete. We used a retrospective, top-down program costing approach. We reviewed study documentation to compile planned and actual costs by site. All costs were annuitized using a 3% discount rate and organized by cost categories: (1) Capital: infrastructure and furnishing, and (2) Installation: capacity building activities and stakeholder engagement. We assumed lifespans of 30 years for infrastructure; 5 years for furnishings; and 3 years for installation activities. Annuitized costs were used to estimate cost per night stayed and per visit for delivery and PNC-related stays. We also modeled theoretical utilization and cost scenarios. The average setup cost of one MWH was $85,284 (capital: 76%; installation: 24%). Annuitized setup cost per MWH was USD$12,516 per year. At an observed occupancy rate of 39%, setup cost per visit to the MWH was USD$70, while setup cost per night stayed was USD$6. The cost of stakeholder engagement activities was underbudgeted by half at the beginning of this project.This analysis serves as a planning resource for governments and implementers that are considering MWHs as a component of their overall maternal and child health strategy. Planning considerations should include the annuitized cost, value of capacity building and stakeholder engagement, and that cost per bed night and visit are dependent upon utilization.

Progress towards unique patient identification and case-based surveillance within the Southern African development community.

Population mobility makes patient-tracking and care linkage in the South African Development Community (SADC) challenging. Case-based surveillance (CBS) through individual-level clinical data linked with a unique patient-identifier (UPI) is recommended. We conducted a mixed-methods landscape analysis of UPI and CBS implementation within selected SADC countries, this included: (1) SADC UPI implementation literature review; (2) assessment of UPI and CBS implementation for high HIV-prevalence SADC countries; (3) UPI implementation case-study in selected South African primary healthcare (PHC) facilities. Research into CBS and UPI implementation for the SADC region is lacking. Existing patient-identification methods often fail and limit patient-tracking. Paper-based records and poor integration between health-information systems further restrict patient-tracking. Most countries were in the early-middle stages of CBS and faced UPI challenges. Our South African case-study found that the UPI often goes uncaptured. Difficulties tracking patients across prevention and care cascades will continue until a functional and reliable UPI is available.

"I want one nurse who is friendly to talk to me properly like a friend": Learner preferences for HIV and contraceptive service provision in Gauteng, South Africa.

Background: Research with adolescents indicates that youth aged 15-24 years, especially females, are at high risk for HIV infection. The overall HIV prevalence among youth in this age group was 6.2% estimated in 2022. In addition, > 800,000 adolescents are newly infected with HIV every year and 79% of these infections occur in sub-Saharan Africa. The health service provision preferences and needs of adolescents are critical to reaching this population. Methods: This qualitative study was conducted with learners from three public secondary schools in Gauteng, South Africa. Using convenience sampling, 22 in-depth stakeholder interviews (KIIs) with stakeholders and 8 focus group discussions (FGDs) with 55 learners aged ≥ 15, were conducted between March and October 2018. Learners < 18 were given assent and parental consent forms, whilst those ≥ 18 could consent of their own accord. KIIs and FGDs were conducted in private venues in the preferred language by trained interviewers and audio-recorded. Audio files were transcribed verbatim and translated into English if needed. Data were analysed thematically using NVivo version 11. Results: The findings from both stakeholders and learners indicate many critical accessibility barriers which include: negative healthcare staff attitudes from older judgemental staff; stigmatisation from healthcare workers, the community as well as family; a lack of private consulting spaces and no confidentiality of patient information at facilities; inconvenient clinic operating times; long queues and facility resource issues. Both groups of participants suggested that accessibility to healthcare could be improved through value-added services (including free Wi-Fi and food), social gatherings and educational information sessions, as well as being staffed by younger, friendlier, confidential and non-judgemental staff in a private healthcare setting. Conclusion: It is clear that there are many critical barriers that deter learners from accessing HIV and contraceptive services. Provision of private rooms and trying to ensure information confidentiality for youth-friendly services at locations and times that can be easily accessed by learners is key. Greater emphasis on learner-parent-teacher communication around sexual health education at school is needed along with making this information being more readily available to learners.

Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa.

INTRODUCTION: Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa. METHODS AND ANALYSIS: We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs. ETHICS AND DISSEMINATION: Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04242992.

Quasi-experimental evaluation of a financial incentive for first-dose COVID-19 vaccination among adults aged ≥60 years in South Africa.

INTRODUCTION: COVID-19 vaccination coverage in South Africa (RSA) remains low despite increased access to vaccines. On 1 November 2021, RSA introduced the Vooma Voucher programme which provided a small guaranteed financial incentive, a Vooma Voucher redeemable at grocery stores, for COVID-19 vaccination among older adults, a population most vulnerable to serious illness, hospitalisation and death. However, the association of financial incentives with vaccination coverage remains unclear. METHODS: We evaluated the association of the conditional economic incentive programme with first-dose vaccination rates among adults (aged ≥60 years) through a quasi-experimental cohort study. The Vooma Voucher programme was a nationwide vaccination incentive programme implemented for adults aged ≥60 years from 1 November 2021 to 28 February 2022. We ran ITS models to evaluate the Vooma Voucher programme at national and provincial levels. We used data between 1 October 2021 and 27 November 2021 in models estimated at the daily level. Individuals who received their first vaccine dose received a text message to access a ZAR100 ($~7) voucher that was redeemable at grocery stores. RESULTS: The Vooma Voucher programme was associated with a 7.15%-12.01% increase in daily first-dose vaccinations in November 2021 compared with late October 2021. Overall, the incentive accounted for 6476-10 874 additional first vaccine doses from 1 November to 27 November 2021, or 8.31%-13.95% of all doses administered to those aged ≥60 years during that period. This result is robust to the inclusion of controls for the number of active vaccine delivery sites and for the nationwide Vooma vaccination weekend initiative (12 November to 14 November), both of which also increased vaccinations through expanded access to vaccines and demand creation activities. CONCLUSIONS: Financial incentives for COVID-19 vaccination led to a modest increase in first-dose vaccinations among older adults in RSA. Financial incentives and expanded access to vaccines may result in higher vaccination coverage. TRIAL REGISTRATION NUMBER SANCTR: DOH-27-012022-9116.

Similar costs and outcomes for differentiated service delivery models for HIV treatment in Uganda.

This cost-outcome study estimated, from the perspective of the service provider, the total annual cost per client on antiretroviral therapy (ART) and total annual cost per client virally suppressed (defined as < 1000 copies/ml at the time of the study) in Uganda in five ART differentiated service delivery models (DSDMs). These included both facility- and community-based models and the standard of care (SOC), known as the facility-based individual management (FBIM) model. The Ministry of Health (MOH) adopted guidelines for DSDMs in 2017 and sought to measure their costs and outcomes, in order to effectively plan for their resourcing, implementation, and scale-up. In Uganda, the standard of care (FBIM) is considered as a DSDM option for clients requiring specialized treatment and support, or for those who select not to join an alternative DSDM. Note that clients on second-line regimes and considered as "established on treatment" can join a suitable DSDM.Using retrospective client record review of a cohort of clients over a two-year period, with bottom-up collection of clients' resource utilization data, top-down collection of above-delivery level and delivery-level providers' fixed operational costs, and local unit costs. Forty-seven DSDMs located at facilities or community-based points in the four regions of Uganda were included in the study, with 653 adults on ART (> 18 years old) enrolled in a DSDM. The study found that retention in care was 98% for the sample as a whole [96-100%], and viral suppression, 91% [86-93%]. The mean cost to the provider (MOH or NGO implementers) was $152 per annum per client treated, ranging from $141 to $166. Differences among the models' costs were largely due to clients' ARV regimens and the proportions of clients on second line regimens. Service delivery costs, excluding ARVs, other medicines and laboratory tests, were modest, ranging from $9.66-16.43 per client per year. We conclude that differentiated ART service delivery in Uganda achieved excellent treatment outcomes at a cost similar to the standard of care. While large budgetary savings might not be immediately realized, the reallocation of "saved" staff time could improve health system efficiency and with their equivalent or better outcomes and large benefits to clients, client-centred differentiated models would nevertheless add great societal value.

Reduction in initiations of HIV treatment in South Africa during the COVID pandemic.

BACKGROUND: In response to the global pandemic of COVID-19, countries around the world began imposing stay-at-home orders, restrictions on transport, and closures of businesses in early 2020. South Africa implemented a strict lockdown in March 2020 before its first COVID-19 wave started, gradually lifted restrictions between May and September 2020, and then re-imposed restrictions in December 2020 in response to its second wave. There is concern that COVID-19-related morbidity and mortality, fear of transmission, and government responses may have led to a reduction in antiretroviral treatment (ART) initiations for HIV-infected individuals in countries like South Africa. METHODS: We analyzed national, public sector, facility-level data from South Africa's District Health Information System (DHIS) from January 2019 to March 2021 to quantify changes in ART initiation rates stratified by province, setting, facility size and type and compared the timing of these changes to COVID-19 case numbers and government lockdown levels. We excluded facilities with missing data, mobile clinics, and correctional facilities. We estimated the total number of ART initiations per study month for each stratum and compared monthly totals, by year. RESULTS: At the 2471 facilities in the final data set (59% of all ART sites in the DHIS), 28% fewer initiations occurred in 2020 than in 2019. Numbers of ART initiations declined sharply in all provinces in April-June 2020, compared to the same months in 2019, and remained low for the rest of 2020, with some recovery between COVID-19 waves in October 2020 and possible improvement beginning in March 2021. Percentage reductions were largest in district hospitals, larger facilities, and urban areas. After the initial decline in April-June 2020, most provinces experienced a clear inverse relationship between COVID-19 cases and ART initiations but little relationship between ART initiations and lockdown level. CONCLUSIONS: The COVID-19 pandemic and responses to it resulted in substantial declines in the number of HIV-infected individuals starting treatment in South Africa, with no recovery of numbers during 2020. These delays may lead to worse treatment outcomes for those with HIV and potentially higher HIV transmission. Exceptional effort will be needed to sustain gains in combatting HIV.

Men missing from the HIV care continuum in sub-Saharan Africa: a meta-analysis and meta-synthesis.

INTRODUCTION: Men are missing along the HIV care continuum. However, the estimated proportions of men in sub-Saharan Africa meeting the UNAIDS 95-95-95 goals vary substantially between studies. We sought to estimate proportions of men meeting each of the 95-95-95 goals across studies in sub-Saharan Africa, describe heterogeneity, and summarize qualitative evidence on factors influencing care engagement. METHODS: We systematically searched PubMed and Embase for peer-reviewed articles published between 1 January 2014 and 16 October 2020. We included studies involving men ≥15 years old, with data from 2009 onward, reporting on at least one 95-95-95 goal in sub-Saharan Africa. We estimated pooled proportions of men meeting these goals using DerSimonion-Laird random effects models, stratifying by study population (e.g. studies focusing exclusively on men who have sex with men vs. studies that did not), facility setting (healthcare vs. community site), region (eastern/southern Africa vs. western/central Africa), outcome measurement (e.g. threshold for viral load suppression), median year of data collection (before vs. during or after 2017) and quality criteria. Data from qualitative studies exploring barriers to men's HIV care engagement were summarized using meta-synthesis. RESULTS AND DISCUSSION: We screened 14,896 studies and included 129 studies in the meta-analysis, compiling data over the data collection period. Forty-seven studies reported data on knowledge of serostatus, 43 studies reported on antiretroviral therapy use and 74 studies reported on viral suppression. Approximately half of men with HIV reported not knowing their status (0.49 [95% CI, 0.41-0.58; range, 0.09-0.97]) or not being on treatment (0.58 [95% CI, 0.51-0.65; range, 0.07-0.97]), while over three-quarters of men achieved viral suppression on treatment (0.79 [95% CI, 0.77-0.81; range, 0.39-0.97]. Heterogeneity was high, with variation in estimates across study populations, settings and outcomes. The meta-synthesis of 40 studies identified three primary domains in which men described risks associated with engagement in HIV care: perceived social norms, health system challenges and poverty. CONCLUSIONS: Psychosocial and systems-level interventions that change men's perceptions of social norms, improve trust in and accessibility of the health system, and address costs of accessing care are needed to better engage men, especially in HIV testing and treatment.

One Pill, Once a Day: Simplified Treatment Regimens and Retention in HIV Care.

Simplified drug regimens may improve retention in care for persons with chronic diseases. In April 2013, South Africa adopted a once-daily single-pill human immunodeficiency virus (HIV) treatment regimen as the standard of care, replacing a multiple-pill regimen. Because the regimens had similar biological efficacy, the shift to single-pill therapy offered a real-world test of the impact of simplified drug-delivery mechanisms on patient behavior. Using a quasi-experimental regression discontinuity design, we assessed retention in care among patients starting HIV treatment just before and just after the guideline change. The study included 4,484 patients starting treatment at a large public sector clinic in Johannesburg, South Africa. The share of patients prescribed a single-pill regimen increased by over 40 percentage points between March and April 2013. Initiating treatment after the policy change was associated with 11.7-percentage-points' higher retention at 12 months (95% confidence interval: -2.2, 29.4). Findings were robust to different measures of retention, different bandwidths, and different statistical models. Patients starting treatment early in HIV infection-a key population in the test-and-treat era-experienced the greatest improvements in retention from single-pill regimens.

Reduction in initiations of drug-sensitive tuberculosis treatment in South Africa during the COVID-19 pandemic: Analysis of retrospective, facility-level data.

In response to the global pandemic of COVID-19, South Africa implemented a strict lockdown in March 2020 before its first COVID-19 wave started, gradually lifted restrictions between May and September 2020, and then re-imposed restrictions in December 2020 in response to its second wave. There is concern that COVID-19-related morbidity and mortality, the deprioritization of TB activities, fear of transmission, and societal restrictions led to a reduction in tuberculosis (TB) treatment initiations. We analysed monthly public sector, facility-level data from South Africa's District Health Information System (DHIS) from January 2019 to April 2021 to quantify changes in TB treatment initiation numbers stratified by province, setting, and facility type and compared the timing of these changes to COVID-19 case numbers and government lockdown levels. At the 1189 facilities that reported observations for all 28 months of our study period, TB treatment initiations in 2020 were 20.4% lower than in 2019 and 21.9% lower in the first four months of 2021 than in 2019. At the 3669 facilities that reported observations in ≤28 months, numbers of TB treatment initiations declined sharply in all provinces in May-August 2020, compared to the same months in 2019. After recovering somewhat in the last four months of 2020, numbers plummeted again in early 2021. Percentage reductions were somewhat larger in urban and peri-urban areas than in rural areas. Most provinces experienced a clear inverse relationship between COVID-19 cases and TB treatment initiations but little relationship between TB treatment initiations and lockdown level. The COVID-19 pandemic and responses to it resulted in substantial declines in the number of individuals starting treatment for TB in South Africa and risked progress toward achieving TB management goals. Exceptional effort will be needed to sustain gains in combating TB.