Integrating 'undetectable equals untransmittable' into HIV counselling in South Africa: the development of locally acceptable communication tools using intervention mapping.

BACKGROUND: The global campaign for "Undetectable equals Untransmittable" (U = U) seeks to spread awareness of HIV treatment as prevention, aiming to enhance psychological well-being and diminish stigma. Despite its potential benefits, U = U faces challenges in Sub-Saharan Africa, with low awareness and hesitancy to endorse it. We sought to develop a U = U communications intervention to support HIV counselling in primary healthcare settings in South Africa. METHODS: We used Intervention Mapping (IM), a theory-based framework to develop the "Undetectable and You" intervention for the South African context. The six steps of the IM protocol were systematically applied to develop the intervention including a needs assessment consisting of a systematic review and qualitative research including focus group discussions (FGD) and key informant (KI) interviews. Program objectives and target population were determined before designing the intervention components and implementation plan. RESULTS: The needs assessment indicated low global U = U awareness, especially in Africa, and scepticism about its effectiveness. Lay counsellors and clinic managers stressed the need for a simple and standardized presentation of U = U addressing both patients' needs for encouragement and modelling of U = U success but also clear guidance toward ART adherence behaviour. Findings from each step of the process informed successive steps. Our final intervention consisted of personal testimonials of PLHIV role models and their partners, organized as an App to deliver U = U information to patients in primary healthcare settings. CONCLUSIONS: We outline an intervention development strategy, currently in evaluation stage, utilizing IM with formative research and input from key U = U stakeholders and people living with HIV (PLHIV).

Improving patient-centred counselling skills among lay healthcare workers in South Africa using the Thusa-Thuso motivational interviewing training and support program.

We developed a motivational interviewing (MI) counselling training and support program for lay counsellors in South Africa-branded "Thusa-Thuso-helping you help", commonly referred to as Thusa-Thuso. We present the results of a pilot study to determine the program's impact on MI technical skills and qualitatively assess the feasibility of a training-of-trainers (TOT) scale-up strategy among counselling staff of non-governmental (NGO) support partners of the human immunodeficiency virus (HIV) treatment program in South Africa. We enrolled adult (≥ 18 years) lay counsellors from ten primary healthcare clinics in Johannesburg (South Africa) selected to participate in the Thusa-Thuso training and support program. Counsellors attended the ten-day baseline and quarterly refresher training over 12 months (October 2018-October 2019). Each counsellor submitted two audio recordings of mock counselling sessions held during the ten-day baseline training and two additional recordings of sessions with consenting patients after each quarterly contact session. We reviewed the recordings using the MI treatment integrity (MITI) coding system to determine MI technical (cultivating change talk and softening sustain talk) and relational (empathy and partnership) competency scores before and after training. After 12 months of support with pilot site counsellors, we were asked to scale up the training to NGO partner team trainers in a once-off five-day Training of trainers (TOT) format (n = 127 trainees from November 2020 to January 2021). We report TOT training experiences from focus group discussions (n = 42) conducted six months after the TOT sessions. Of the 25 enrolled lay counsellors from participating facilities, 10 completed the 12-month Thusa-Thuso program. Attrition over the 12 months was caused by death (n = 3), site exclusion/resignations (n = 10), and absence (n = 2). MI competencies improved as follows: the technical skills score increased from a mean of 2.5 (standard deviation (SD): 0.8) to 3.1 (SD: 0.5), with a mean difference of 0.6 (95% confidence interval (CI): 0.04, 0.9). The MI relational skills score improved from a mean of 3.20 (SD: 0.7) to 3.5 (SD: 0.6), with a mean difference of 0.3 (95% CI: -0.3, 8.5). End-point qualitative data from the counsellors highlighted the value of identifying and addressing specific skill deficiencies and the importance of counsellors being able to self-monitor skill development using the MITI review process. Participants appreciated the ongoing support to clarify practical MI applications. The TOT program tools were valuable for ongoing on-the-job development and monitoring of quality counselling skills. However, the MITI review process was perceived to be too involved for large-scale application and was adapted into a scoring form to document sit-in mentoring sessions. The Thusa-Thuso MI intervention can improve counsellor motivation and skills over time. In addition, the program can be scaled up using an adapted TOT process supplemented with fidelity assessment tools, which are valuable for skills development and ongoing maintenance. However, further studies are needed to determine the effect of the Thusa-Thuso program on patient ART adherence and retention in care. Trial registration: Pan African Clinical Trials Registry No: PACTR202212796722256 (12 December 2022).

Who is providing HIV testing services? The profile of lay counsellors providing HIV testing services in Johannesburg, South Africa in the treat-all era.

BACKGROUND: Lay counsellors are critical in sustaining access to HIV testing services (HTS) and psychosocial support for persons living with HIV (PLHIV). We aimed to describe the professional and psychosocial profiles of lay counsellors in primary healthcare (PHC) clinics in Johannesburg, South Africa under the universal-test-and-treat (UTT) policy context. METHODS: We conducted a descriptive analysis of a cross-sectional survey among adult (≥ 18 years) lay counsellors from 20 PHC facilities (2-3/ clinic) in Johannesburg, South Africa. Consenting counsellors were interviewed between June 2018 and March 2019. We report on counsellors' demographic profiles, training, work experience, and mental and emotional well-being. RESULTS: Overall, 55 consenting adult (≥ 18 years) lay counsellors (92.7% female, median age 37 years, interquartile range [IQR]: 33-44, and 27.3% HIV diagnosed) were surveyed. Most (85.5%) were Department of Health lay counsellors receiving a volunteer stipend at the time. Overall, 56.4% had been working as counsellors for five years or longer. The majority (87%) had completed the National HIV Testing Services Policy Guidelines-recommended 10-day basic counselling training, but 45.2% had not completed refresher training within the guideline's required 24 months. Reported operational barriers include lack of designated space for counselling (56.4%), inadequate professional supervision and support (40.7%) and insufficient emotional support (over 56.4%), and 60% were overwhelmed by their workload. A total of 18.2% had major depressive symptoms, and the same proportion scored low for psychological well-being. While most (87.3%) reported moderate job satisfaction, 50.9% actively sought alternative employment. CONCLUSION: Despite lay counsellors' significant role in delivering HIV care in South Africa, there has been minimal investment in their skills development, emotional support, and integration into the formal health workforce. Counsellors' persisting unmet psychosocial, training, and professional needs could impact their efficacy in the UTT era.

Designing effective U = U communication strategies considering the needs of PLHIV, their partners, and healthcare worker constraints in South African clinics.

INTRODUCTION: We sought to understand the Undetectable = Untransmittable (U = U) communication needs of persons living with HIV (PLHIV) and barriers to U = U communication among healthcare providers (HCPs) in South Africa. METHODS: We conducted five focus group discussions (FGDs) with HCPs (N = 42) including nurses and counsellors from primary healthcare clinics (PHCs) in the Gauteng and Free State Provinces of South Africa, three FGDs (N = 27) with PLHIV recruited by snowball sampling from civil society organizations, and 27 in-depth interviews (IDIs) with recently diagnosed PLHIV in Johannesburg. IDIs and FGDs were audio recorded, transcribed, translated to English, and analysed thematically. RESULTS: PLHIV were largely unaware and sceptical of U = U as the message appeared to contradict the mainstream HIV prevention clinical guidance. The low viral load (VL) knowledge further reduced confidence in U = U. PLHIV need support and guidance on the best approaches for sharing U = U information and disclosing their VL status to their partners, highlighting the central role of community understanding of U = U and VL to mediate the desired stigma reduction, social acceptance and emotional benefits of U = U for PLHIV. HCPs were uneasy about sharing U = U due to concerns about risk compensation and ART non-adherence and worried about enabling any ensuing HIV transmission. HCPs also need a simple, unambiguous, and consistent narrative for U = U, integrated with other HIV prevention messages. PLHIV and HCPs alike recommended a patient-centred approach to communicating U = U, focusing primarily on attaining viral suppression and emphasizing that condomless sex is only safe during periods of ART adherence. CONCLUSIONS: These data highlight the need for simple U = U communication support targeting both HCP and PLHIV. Culturally appropriate communication materials, with training and ongoing mentorship of the clinic staff, are essential to improve patient-centred U = U communication in clinics.

"I was scared dating who would take me with my status?"-Living with HIV in the era of UTT and U = U: A qualitative study in Johannesburg, South Africa.

South Africa rolled out Universal Test-and-Treat (UTT) in 2016, extending treatment eligibility to all persons living with HIV (PLHIV). We sought to understand how PLHIV in Johannesburg, South Africa, interpret and experience their HIV status, five years into the UTT era. In May 2021, we conducted in-depth interviews (IDI) (N = 27) with adult (≥18 years) PLHIV referred by HIV counsellors at three peri-urban primary healthcare clinics. We also conducted three focus group discussions (FGDs) (N = 27) with adult PLHIV recruited from clinics or from civil society organisations through snowball sampling. Follow-up interviews were conducted with 29 IDI and FGD participants. Participants were asked to reflect on their HIV diagnosis, what their HIV status meant to them and how, if at all, being HIV-positive affected their lives. Interviews and focus group discussions were audio-recorded, transcribed, translated to English, and analysed using a grounded theory approach. Participants perceived that HIV was common, that PLHIV could live a normal life with antiretroviral therapy (ART), and that ART was widely accessible. However, HIV elicited feelings of guilt and shame as a sexually transmitted disease. Participants used the language of "blame" in discussing HIV transmission, citing their own reckless behaviour or blaming their partner for infecting them. Participants feared transmitting HIV to others and felt responsible for avoiding transmission. To manage transmission anxiety, participants avoided sexual relationships, chose HIV-positive partners, and/or insisted on using condoms. Many participants feared-or had previously experienced-rejection by partners due to their HIV status and reported hiding their medication, avoiding disclosure, or avoiding relationships altogether. Most participants were not aware that undetectable HIV is untransmittable (U = U). Participants who were aware of U = U expressed less anxiety about transmitting HIV to others and greater confidence in having relationships. Despite perceiving HIV as a manageable chronic condition, PLHIV still faced transmission anxiety and fears of rejection by their partners. Disseminating information on U = U could reduce the psychosocial burdens of living with HIV, encourage open communication with partners, and remove barriers to HIV testing and treatment adherence.

Health-related quality of life and psychological distress among adults in Tanzania: a cross-sectional study.

BACKGROUND: Little data is available on health-related quality of life (HRQoL) and mental health of the general population in Tanzania. We aimed to describe HRQoL and level of psychological distress among adults in Mbeya and Songwe Regions of Tanzania. METHODS: We conducted a cross-sectional study between April and October 2019 in Mbeya and Songwe Regions. Data were collected using the Medical Outcomes Short Form-36 (SF-36) questionnaire and the Page Kessler Psychological Distress Scale (K10). We described demographic characteristics of participants and used log-binomial regression to identify participant characteristics associated with psychological distress (K10 score ≥ 20). RESULTS: A total of 393 adults were enrolled. The participants had a median age of 29 years (IQR 23-40) and 54.2% were male. Participants reported a physical component summary score (PCS) with a mean of 54.7 (SD7.1) and a mental component summary score (MCS) with a mean of 55.5 (SD5.1). Older participants (≥ 40 year) and those that were divorced/widowed reported lower physical functioning, energy/vitality and emotional well-being compared to their counterparts (p < 0.05). In terms of psychological distress, majority of participants (78.4%; 305/389) reported that they were likely to be well (K10 score < 20), while 13.4% (52/389) reported to have mild (K10 score 20-24), 5.7% (22/389) moderate (K10 score 25-29), and 2.6% (10/389) severe (K10 score ≥ 30) psychological distress. CONCLUSIONS: Physical function and mental well-being in this adult population from Tanzania were lower than that reported in other similar research in Tanzania and other African countries. This study provides valuable references for other research initiatives and clinical services in this region.

Using intervention mapping in motivational interviewing training to improve ART uptake in Gauteng, South Africa.

In South Africa, lay HIV counsellors are at the forefront of many HIV-related behavioural interventions. However, they have limited formal counselling training and little ongoing in-service support, leading to considerable variability in approaches to counselling. We describe the use of Intervention Mapping to develop a motivational interviewing counselling training and support program, titled "Thusa-Thuso - helping you help", for lay HIV counsellors practising in primary health care clinics in South Africa. The program is contextually relevant, locally-produced, scalable, and is designed to impart sustained motivational interviewing counselling skills in lay HIV counsellors for improved antiretroviral therapy (ART) uptake in the universal-test-and-treat era.

HIV and ART related knowledge among newly diagnosed patients with HIV under the universal-test-and-treat (UTT) policy in Johannesburg, South Africa.

South Africa implemented Universal Test & Treat (UTT) guidelines in September 2016. We examine HIV/ART knowledge among newly diagnosed from a prospective study enrolling newly diagnosed HIV-positive adults, under same-day ART policy, at four primary health clinics in Johannesburg, South Africa. We describe factors associated with high HIV/ART related knowledge score among newly diagnosed patients using Poisson regression. We included 652 HIV positive adults (64.1% female; median age 33 years (IQR: 28-39). Overall, 539 (82.7%) patients were classified as having high HIV/ART knowledge, 14.7% medium knowledge and 2.6% had low knowledge. HIV/ART knowledge was mainly associated to high English literacy (aRR 0.9 Medium vs High, 95% CI: 0.8-0.9; aRR 0.7 for Low vs High: 95% CI: 0.6-0.9). However, patients who did not disclose their intentions for HIV test (aRR 0.9, not disclosed intentions vs having disclosed intentions to test, 95% CI: 0.8-0.9), participants who indicated concerns with ART (aRR 0.9 moderate to high vs low concerns, 95% CI: 0.8-0.9) were less likely to have high knowledge. Our results highlight a correlation between English literacy and good knowledge. There is a need to make information more accessible in a non-English language. Addressing this gap is critical in achieving the WHO targets.

Changing Knowledge and Attitudes Towards HIV Treatment-as-Prevention and "Undetectable = Untransmittable": A Systematic Review.

People on HIV treatment with undetectable virus cannot transmit HIV sexually (Undetectable = Untransmittable, U = U). However, the science of treatment-as-prevention (TasP) may not be widely understood by people with and without HIV who could benefit from this information. We systematically reviewed the global literature on knowledge and attitudes related to TasP and interventions providing TasP or U = U information. We included studies of providers, patients, and communities from all regions of the world, published 2008-2020. We screened 885 papers and abstracts and identified 72 for inclusion. Studies in high-income settings reported high awareness of TasP but gaps in knowledge about the likelihood of transmission with undetectable HIV. Greater knowledge was associated with more positive attitudes towards TasP. Extant literature shows low awareness of TasP in Africa where 2 in 3 people with HIV live. The emerging evidence on interventions delivering information on TasP suggests beneficial impacts on knowledge, stigma, HIV testing, and viral suppression.Review was pre-registered at PROSPERO: CRD42020153725.

RESUMEN: Las personas en tratamiento contra el VIH con virus indetectable no pueden transmitir el VIH sexualmente (indetectable = intransmisible, U = U por sus siglas en inglés). Pero, la ciencia del tratamiento como prevención (TasP, por sus siglas en inglés) puede que no sea ampliamente comprendida por personas con y sin VIH que podrían beneficiarse. Revisamos sistemáticamente la literatura mundial sobre conocimientos y actitudes relacionados con TasP e intervenciones que proporcionan información TasP o U = U, 2008­2020. Incluimos estudios de proveedores, pacientes y comunidades de todas las regiones del mundo. Se examinaron 885 artículos y resúmenes y se identificaron 72 para su inclusión. Los estudios en entornos de ingresos altos informaron un alto conocimiento de TasP pero existen lagunas en el conocimiento sobre la probabilidad de transmisión del VIH indetectable. Un mayor conocimiento se asoció con actitudes más positivas hacia TasP. La literatura existente muestra un escaso conocimiento de TasP en África, donde viven 2 de cada 3 personas con VIH. La evidencia emergente sobre intervenciones que brindan información sobre TasP sugiere impactos positivos en el conocimiento, el estigma, las pruebas del VIH y la supresión viral.

Self-reported motivators for HIV testing in the treat-all era among HIV positive patients in Johannesburg, South Africa.

ABSTRACT: To explore associations between self-reported ill-health as a primary motivator for HIV-testing and socio-demographic factors.Four local primary healthcare clinics in Johannesburg, South Africa.A total of 529 newly HIV diagnosed adults (≥18 years) enrolled from October 2017 to August 2018, participated in the survey on the same day of diagnosis.Testing out of own initiative or perceived HIV exposure was categorized as asymptomatic. Reporting ill-health as the main reason for testing was categorized as symptomatic. Modified Poisson regression was used to evaluate predictors of motivators for HIV testing.Overall, 327/520 (62.9%) participants reported symptoms as the main motivator for testing. Among the asymptomatic, 17.1% reported potential HIV exposure as a reason for testing, while 20.0% just wanted to know their HIV status. Baseline predictors of symptom-related motivators for HIV testing include disclosing intention to test (aPR 1.4 for family/friend/others vs partners/spouse, 95% CI: 1.1-1.8; aPR 1.4 for not disclosing vs partners/spouse, 95% CI: 1.1-1.7), and HIV testing history (aPR 1.2 for last HIV test >12-months ago vs last test 12-months prior, 95% CI: 1.0-1.5; aPR 1.3 for never tested for HIV before vs last test 12-months prior, 95%CI:1.0-1.6).Findings indicate that newly diagnosed HIV positive patients still enter care because of ill-health, not prevention purposes. Increasing early HIV testing remains essential to maximize the benefits of expanded ART access.

Understanding the Reasons for Deferring ART Among Patients Diagnosed Under the Same-Day-ART Policy in Johannesburg, South Africa.

We aimed to examine the correlates of antiretroviral therapy (ART) deferral to inform ART demand creation and retention interventions for patients diagnosed with HIV during the Universal Test and Treat (UTT) policy in South Africa. We conducted a cohort study enrolling newly diagnosed HIV-positive adults (≥ 18 years), at four primary healthcare clinics in Johannesburg between October 2017 and August 2018. Patients were interviewed immediately after HIV diagnosis, and ART initiation was determined through medical record review up to six-months post-test. ART deferral was defined as not starting ART six months after HIV diagnosis. Participants who were not on ART six-months post-test were traced and interviewed telephonically to determine reasons for ART deferral. Modified Poisson regression was used to evaluate correlates of six-months ART deferral. We adjusted for baseline demographic and clinical factors. We present crude and adjusted risk ratios (aRR) associated with ART deferral. Overall, 99/652 (15.2%) had deferred ART by six months, 20.5% men and 12.2% women. Baseline predictors of ART deferral were older age at diagnosis (adjusted risk ratio (aRR) 1.5 for 30-39.9 vs 18-29.9 years, 95% confidence intervals (CI): 1.0-2.2), disclosure of intentions to test for HIV (aRR 2.2 non-disclosure vs disclosure to a partner/spouse, 95% CI: 1.4-3.6) and HIV testing history (aRR 1.7 for > 12 months vs < 12 months/no prior test, 95% CI: 1.0-2.8). Additionally, having a primary house in another country (aRR 2.1 vs current house, 95% CI: 1.4-3.1) and testing alone (RR 4.6 vs partner/spouse support, 95% CI: 1.2-18.3) predicted ART deferral among men. Among the 43/99 six-months interviews, women (71.4%) were more likely to self-report ART initiation than men (RR 0.4, 95% CI: 0.2-0.8) and participants who relocated within SA (RR 2.1 vs not relocated, 95% CI: 1.2-3.5) were more likely to still not be on ART. Under the treat-all ART policy, nearly 15.2% of study participants deferred ART initiation up to six months after the HIV diagnosis. Our analysis highlighted the need to pay particular attention to patients who show little social preparation for HIV testing and mobile populations.

Attrition in HIV care following HIV diagnosis: a comparison of the pre-UTT and UTT eras in South Africa.

INTRODUCTION: Policies for Universal Test & Treat (UTT) and same-day initiation (SDI) of antiretroviral therapy (ART) were instituted in South Africa in September 2016 and 2017 respectively. However, there is limited evidence on whether these changes have improved patient retention after HIV diagnosis. METHODS: We enrolled three cohorts of newly diagnosed HIV-infected adults from two primary health clinics in Johannesburg from April to November 2015 (Pre-UTT, N = 144), May-September 2017 (UTT, N = 178) and October-December 2017 (SDI, N = 88). A baseline survey was administered immediately after HIV diagnosis after which follow-up using clinical records (paper charts, electronic health records and laboratory data) ensued for 12 months. The primary outcome was patient loss to follow-up (being >90 days late for the last scheduled appointment) at 12 months post-HIV diagnosis. We modelled attrition across HIV policy periods with Cox proportional hazard regression. RESULTS: Overall, 410 of 580 screened HIV-positive patients were enrolled. Overall, attrition at 12 months was 30% lower in the UTT guideline period (38.2%) compared to pre-UTT (47.2%, aHR 0.7, 95% CI: 0.5 to 1.0). However, the total attrition was similar between the SDI (47.7%) and pre-UTT cohorts (aHR 1.0, 95% CI: 0.7 to 1.5). Older age at HIV diagnosis (aHR 0.5 for ≥40 vs. 25 to 29 years, 95% CI: 0.3 to 0.8) and being in a non-marital relationship (aHR 0.5 vs. being single, 95% CI: 0.3 to 0.8) protected against LTFU at 12 months, whereas LTFU rates increased with longer travel time to the diagnosing clinic (aHR 1.8 for ≥30 minutes vs. ≤15 minutes, 95% CI: 1.1 to 3.1). In analyses adjusted for the time-varying ART initiation status, compared to the pre-ART period of care, the hazard of on-ART LTFU was 90% higher among participants diagnosed under the SDI policy compared to pre-UTT (aHR 1.9, 95% CI: 1.1 to 2.9). CONCLUSIONS: Overall, nearly two-fifths of HIV positive patients are likely to disengage from care by 12 months after HIV diagnosis under the new SDI policy. Furthermore, the increase in on-ART patient attrition after the introduction of the SDI policy is cause for concern. Further research is needed to determine the best way for rapidly initiating patients on ART and also reducing long-term attrition from care.

Health provider perspectives on the implementation of the same-day-ART initiation policy in the Gauteng province of South Africa.

BACKGROUND: In September 2016, South Africa (SA) began implementing the universal-test-and-treat (UTT) policy in hopes of attaining the UNAIDS 90-90-90 targets by 2020. The SA National Department of Health provided a further directive to initiate antiretroviral therapy (ART) on the day of HIV diagnosis in September 2017. We conducted a qualitative study to determine the progress in implementing UTT and examine health providers' perspectives on the implementation of the same-day initiation (SDI) policy, six months after the policy change. METHODS: We conducted in-depth interviews with three professional nurses, and four HIV lay counsellors of five primary health clinics in the Gauteng province, between October and December 2017. In September 2018, we also conducted a focus group discussion with ten professional nurses/clinic managers from ten clinic facilities. The interviews and focus groups covered the adoption and implementation of UTT and SDI policies. Interviews were conducted in English, Sotho or Zulu and audio-recorded with participant consent. Audio-recordings were transcribed verbatim, translated to English and analysed thematically using NVivo 11. RESULTS: The data indicates inconsistencies across facilities and incongruities between counsellor and nursing provider perspectives regarding the SDI policy implementation. While nurses highlighted the clinical benefits of early ART initiation, they expressed concerns that immediate ART may be overwhelming for some patients, who may be unprepared and likely to disengage from care soon after the initial acceptance of ART. Accordingly, the SDI implementation was slow due to limited patient demand, provider ambivalence to the policy implementations, as well as challenges with infrastructure and human resources. The process for assessing patient readiness was poorly defined by health providers across facilities, inconsistent and counsellor dependent. Providers were also unclear on how to ensure that patients who defer treatment return for ongoing counselling. CONCLUSIONS: Our results highlight important gaps in the drive to achieve the ART initiation target and demonstrate the need for further engagement with health care providers around the implementation of same-day ART initiation, particularly with regards to infrastructural/capacity needs and the management of patient readiness for lifelong ART on the day of HIV diagnosis. Additionally, there is a need for improved promotion of the SDI provision both in health care settings and in media communications to increase patient demand for early and lifelong ART.

Impact of the test and treat policy on delays in antiretroviral therapy initiation among adult HIV positive patients from six clinics in Johannesburg, South Africa: results from a prospective cohort study.

OBJECTIVES: To assess delays to antiretroviral therapy (ART) initiation before and after the Universal Test and Treat (UTT) and the same-day initiation (SDI) of ART policy periods in Johannesburg, South Africa. DESIGN: Prospective cohort study. SETTING: Patients were recruited from six primary health clinics in Johannesburg. PARTICIPANTS: Overall, 1029 newly diagnosed HIV positive adults (≥18 years) were consecutively enrolled by referral from the testing counsellor between April and December 2015 (pre-UTT n=146), July and August 2017 (UTT, n=141) and October 2017 and August 2018 (SDI, n=742). MAIN OUTCOME MEASURES: Cox proportional hazards regression was used to assess predictors of 30 days ART initiation. Additionally, predictors of immediate ART initiation were evaluated using Poisson regression. RESULTS: Overall, 30 days ART proportions were 71.9% overall, 36.9% pre-UTT (44.3% of those eligible), 65.9% under UTT and 79.9% under the SDI policy. The median days to ART initiation declined from 21 pre-UTT (IQR: 15-30) to 8 (IQR: 6-16) under UTT and 5 days (IQR: 0-8) under the SDI policy. However, only 150 (20.2%) of the SDI cohort-initiated ART immediately after HIV diagnosis. Living in a two-adult home (adjusted HR (aHR) 1.2 vs living alone, 95% CI 1.0 to 1.5) increased the likelihood of 30-day ART. Missing baseline cluster of differentiation four (CD4) data decreased the likelihood of 30 days ART by 40% (aHR 0.6 vs CD4 <350 cells/µL, 95% CI 0.5 to 0.7). More women took up immediate ART (adjusted relative risk (aRR) 1.3, 95% CI 1.0 to 1.9). Participants ≥40 years (aRR 0.6 vs 18-24 years, 95% CI 0.4 to 0.9) were less likely to start ART immediately after HIV diagnosis. However, immediate ART rates increased with longer policy implementation time (aRR 0.2 for <3 months vs >10 months, 95% CI 0.1 to 0.4). CONCLUSIONS: The study results highlight a positive move towards earlier ART initiation during the UTT and SDI periods and emphasise a need to increase same-day ART implementation further.

HIV Treatment Outcomes Among Patients Initiated on Antiretroviral Therapy Pre and Post-Universal Test and Treat Guidelines in South Africa.

INTRODUCTION: Officially rolled out on 01 September 2016, South Africa's Universal Test and Treat (UTT) policy calls for first-line antiretroviral treatment (ART) initiation among all known HIV-positive patients, irrespective of CD4 cell count. We evaluate treatment outcomes of patients initiated on first-line ART directly before and after the implementation of UTT. METHODS: We analysed prospectively collected clinical cohort data among ART-naïve adult patients within two HIV clinics in Johannesburg, South Africa. We compare two groups: 1) an unexposed pre-UTT group initiating treatment from 01 December 2014 to 31 May 2015; and 2) an exposed UTT group initiating treatment from 01 December 2016 to 31 May 2017. Primary treatment outcomes included lost to follow-up (LTFU) (>90 days late for the last scheduled visit with no subsequent clinical visit). Cox proportional hazards models were used to estimate the association between pre-UTT vs UTT initiation on LTFU by 12 months. RESULTS: We included 2410 patients. A total of 1267 (52.6%) patients initiated ART before UTT implementation and 1143 (47.4%) after the change in policy. LTFU (adjusted Hazard Ratio (aHR): 1.51; 95% Confidence Interval (CI): 1.16-1.98) between groups and specifically among those initiating with a CD4 cell count ≤500 cells/mm3 (aHR: 1.59; 95% CI: 1.21-2.10) was higher among patients initiating ART under UTT. CONCLUSION: LTFU under UTT proved higher than that of previous periods. Patients initiating first-line therapy under the treat-all policy may often start treatment in better health, subsequently not perceiving a direct benefit to treatment which may deter patients from consistent engagement in HIV treatment programmes.

Women's costs for accessing comprehensive sexual and reproductive health services: findings from an observational study in Johannesburg, South Africa.

BACKGROUND: Evaluating progress towards the Sustainable Development Goal of universal access to sexual and reproductive (SRH) services requires an understanding of the health needs of individuals and what constitutes access to services. We explored women's costs of accessing SRH services in Johannesburg, South Africa and contextualized costs based on estimates of household income. METHODS: We conducted an observational study of women aged 18-49 at a public HIV treatment site and two public primary health care facilities from June 2015 to August 2016. Interviews assessed women's SRH needs (for contraception, fertility problems, menstrual problems, menopause symptoms, sexually transmitted infections (STI), experiences of intimate-partner violence (IPV), and cervical and breast cancer screening) and associated costs. We calculated average and total costs (including out-of-pocket spending, lost income, and estimated value of time spent) for women who incurred costs. We also estimated the total and average costs of meeting all SRH needs in a hypothetical "full needs met" year. Finally, we contextualize SRH spending against a measure of catastrophic expenditure (> 10% of household income). RESULTS: Among the 385 women who participated, 94.8% had at least one SRH need in the prior 12 months; 79.7% incurred costs for accessing care. On average, women spent $28.34 on SRH needs during the prior year. Excluding one HIV-negative woman who spent 112% of her annual income on infertility treatment, HIV-positive women spent more on average annually for SRH care than HIV-negative women. Sixty percent of women reported at least one unmet SRH need. If all participants sought care for all reported needs, their average annual cost would rise to $52.65 per woman. Only two women reported catastrophic expenditure - for managing infertility. CONCLUSIONS: SRH needs are constants throughout women's lives. Small annual costs can become large costs when considered cumulatively over time. As South Africa and other countries grapple with increasing access to SRH services under the rubric of universal access, it is important to remember that individuals incur costs despite free care at the point of service. Policies that address geographic proximity and service quality would be important for reducing costs and ensuring full access to SRH services. Literature on women's financial and economic costs for accessing comprehensive sexual and reproductive health care in low- and middle-income countries is extremely limited, and existing literature often overlooks out-of-pocket costs associated with travel, child care, and time spent accessing services. Using data from a survey of 385 women from a public HIV treatment site and two public primary health care facilities in Johannesburg, we found nearly all women reported at least on sexual and reproductive health need and more than 75% of women incurred costs related to those needs. Furthermore, more than half of women surveyed reported not accessing services for their sexual and reproductive health needs, suggesting a total annual cost of more than $50 USD, on average, to access services for all reported needs. While few women spent more than 10% of their total household income on sexual and reproductive health services in the prior year, needs are constant and costs incur throughout a woman's life suggesting accessing services to meet these needs might still result in financial burden. As South Africa grapples with increasing access to sexual and reproductive health services under the rubric of universal access, it is important to remember that individuals incur costs despite free care at the point of service. Policies that address geographic proximity and service quality would be important for reducing costs and ensuring full access to services.

The impact of adverse events on health-related quality of life among patients receiving treatment for drug-resistant tuberculosis in Johannesburg, South Africa.

BACKGROUND: Adverse events (AEs) are common during treatment of drug-resistant tuberculosis (DR-TB). Little is known about the health-related quality of life (HRQoL) of patients receiving treatment for DR-TB or the effect of AEs on HRQoL. METHODS: We conducted a cross-sectional study among adult patients with laboratory-confirmed rifampicin resistant tuberculosis (TB) on DR-TB treatment at a public-sector outpatient DR-TB clinic in Johannesburg, South Africa between 02/2015-01/2018. Data on HRQoL using the Medical Outcomes Short Form-36 (SF-36) questionnaire and self-reported AEs were collected by trained interviewers through face-to-face interviews. We report averages for the eight major domains and mental (MCS) and physical health (PCS) component summary scores, stratified by whether AEs were reported in the last four weeks. For comparative purposes, we enrolled two other patient groups and included data on a separate group of healthy adults. RESULTS: We enrolled 149 DR-TB patients (median age 36 years IQR 29-43, 55% male, 77.9% HIV-positive, 81% on ART, 61.8% on a standard long-course regimen and 44.3% on DR-TB treatment for less than 6 months). 58/149 (38.9%) patients reported a total of 122 AEs in the preceding 4 weeks, of these the most common were joint pain (n = 22), peripheral neuropathy (n = 16), hearing loss (n = 15), nausea and vomiting (n = 12) and dizziness or vertigo (n = 11). SF-36 domains and summary scores (MCS and PCS) were lower in those who reported an AE compared to those who did not, and both were lower than healthy adults. Compared to those who did not report an AE, patients who reported AEs were more likely to have a low MCS (aRR 2.24 95% CI 1.53-3.27) and PCS (aRR 1.52 95% CI 1.07-2.18) summary score. HRQoL was lower among those on DR-TB treatment for 6 months or less. CONCLUSION: Results show that DR-TB had a substantial impact on patients' quality of life, but that AEs during the early months on treatment may be responsible for reducing HRQoL even further. Our findings highlight the negative effects of injectable agents on HRQoL. Patients require an integrative patient-centered approach to deal with DR-TB and HIV and the potential overlapping toxicities which may be worsened by concurrent treatment.

Impact of Xpert MTB/RIF and decentralized care on linkage to care and drug-resistant tuberculosis treatment outcomes in Johannesburg, South Africa.

BACKGROUND: In 2011, South Africa improved its ability to test for rifampicin-resistant TB (RR-TB) by introducing GeneXpert MTB/RIF. At the same time, the South African National TB program adopted a policy decentralized, outpatient treatment for drug resistant (DR-) TB. We aim to analyze the impact of these changes on linkage to care and DR-TB treatment outcomes. METHODS: We retrospectively matched adult patients diagnosed with laboratory-confirmed RR-TB in Johannesburg from 07/2011-06/2012 (early cohort) and 07/2013-06/2014 (late cohort) with records of patients initiating DR-TB treatment at one of the city's four public sector treatment sites. We determine the proportion of persons diagnosed with RR-TB who initiated DR-TB treatment and report time to treatment initiation (TTI) before and after the implementation of Xpert MTB/RIF roll-out in Johannesburg, South Africa. We conducted a sub-analysis among those who initiated DR-TB treatment at the decentralized outpatient DR-TB centers to determine if delays in treatment initiation have a subsequent impact on treatment outcomes. RESULTS: Five hundred ninety four patients were enrolled in the early cohort versus 713 in the late cohort. 53.8 and 36.8% of patients were diagnosed with multi-drug resistant TB in the early and late cohorts, respectively. The proportion of RR-TB confirmed cases diagnosed by Xpert MTB/RIF increased from 43.4 to 60.5% between the early and late cohorts, respectively. The proportion who initiated treatment increased from 43.1% (n = 256) to 60.3% (n = 430) in the late cohort. Pre-treatment mortality during the early and the late cohort reduced significantly from 17.5 to 5.8% while lost to follow-up remained high. Although TTI reduced by a median of 19 days, from 33 days (IQR 12-52) in the early cohort to 14 days (IQR 7-31) in the late cohort, this did not translate to improved treatment outcomes and we found no difference in terms of treatment success or on-treatment mortality for those that initiated without delay vs. those that deferred initiation. CONCLUSION: Pre-treatment mortality reduced significantly during late Xpert MTB/RIF coverage but there was no significant difference after treatment was initiated. Despite improvements there is still a significant diagnosis and treatment gap for patients diagnosed with RR-TB and improving treatment outcomes remains critical.

Social and behavioral factors associated with failing second-line ART - results from a cohort study at the Themba Lethu Clinic, Johannesburg, South Africa.

Poor adherence is a main challenge to successful second-line ART in South Africa. Studies have shown that patients can re-suppress their viral load following intensive adherence counselling. We identify factors associated with failure to re-suppress on second-line ART. The study was a retrospective cohort study which included HIV-positive adults who experienced an elevated viral load ≥400 copies/ml on second-line ART between January 2013-July 2014, had completed an adherence counselling questionnaire and had a repeat viral load result recorded within 6 months of intensive adherence counselling. Log-binomial regression was used to evaluate the association between patient characteristics and social, behavioral or occupational factors and failure to suppress viral load (≥400 copies/ml). A total of 128 patients were included in the analysis, and of these 39% (n = 50) failed to re-suppress their viral load. Compared to those who suppressed, far more patients who failed to suppress reported living with family (44.2% vs. 23.7%), missing a dose in the past week (53.3% vs. 30.0%), using traditional/herbal medications (63.2% vs. 34.3%) or had symptoms suggestive of depression (57.7% vs. 34.3%). These patient-related factors could be targeted for interventions to reduce the risk for treatment failure and prevent switching to expensive third-line ART.

Treatment initiation among persons diagnosed with drug resistant tuberculosis in Johannesburg, South Africa.

BACKGROUND: In South Africa, roughly half of the drug-resistant TB cases diagnosed are reported to have been started on treatment. We determined the proportion of persons diagnosed with rifampicin resistant (RR-) TB who initiated treatment in Johannesburg after the introduction of decentralized RR-TB care in 2011. METHODS: We retrospectively matched adult patients diagnosed with laboratory-confirmed RR-TB in Johannesburg from 07/2011-06/2012 with records of patients initiating RR-TB treatment at one of the city's four public sector treatment sites (one centralized, three decentralized). Patients were followed from date of diagnosis until the earliest of RR-TB treatment initiation, death, or 6 months' follow-up. We report diagnostic methods and outcomes, proportions initiating treatment, and median time from diagnosis to treatment initiation. RESULTS: 594 patients were enrolled (median age 34 (IQR 29-42), 287 (48.3%) female). Diagnosis was by GenoType MTBDRplus (Hain-Life-Science) line probe assay (LPA) (281, 47.3%), Xpert MTB/RIF (Cepheid) (258, 43.4%), or phenotypic drug susceptibility testing (DST) (30, 5.1%) with 25 (4.2%) missing a diagnosis method. 320 patients (53.8%) had multi-drug resistant TB, 158 (26.6%) rifampicin resistant TB by Xpert MTB/RIF, 102 (17.2%) rifampicin mono-resistance, and 14 (2.4%) extensively drug-resistant TB. 256/594 (43.0%) patients initiated treatment, representing 70.7% of those who were referred for treatment (362/594). 338/594 patients (57.0%) did not initiate treatment, including 104 (17.5%) who died before treatment was started. The median time from sputum collection to treatment initiation was 33 days (IQR 12-52). CONCLUSION: Despite decentralized RR-TB treatment, fewer than half the patients diagnosed in Johannesburg initiated appropriate treatment. Offering treatment at decentralized sites alone is not sufficient; improvements in linking patients diagnosed with RR-TB to effective treatment is essential.