Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial.

BACKGROUND: Approximately 200 000 South Africans acquired HIV in 2021 despite the availability of universal HIV test and treat and pre-exposure prophylaxis (PrEP). The aim of this study was to test the effectiveness of sexual and reproductive health services or peer support, or both, on the uptake of serostatus neutral HIV services or reduction of sexually transmissible HIV. METHODS: We did an open-label, 2 × 2 randomised factorial trial among young people in a mostly rural area of KwaZulu-Natal, South Africa. Inclusion criteria included being aged 16-29 years, living in the mapped geographical areas that were accessible to the area-based peer navigators, being willing and able to provide informed consent, and being willing to provide a dried blood spot for anonymous HIV testing and HIV viral load measurement at 12 months. Participants were randomly allocated by computer-generated algorithm to one of four groups: those in the standard-of-care group were referred to youth-friendly services for differentiated HIV prevention (condoms, universal HIV test and treat with antiretroviral therapy, and PrEP if eligible); those in the sexual and reproductive health services group received baseline self-collected specimens for sexually transmitted infection (STI) testing and referral to integrated sexual and reproductive health and HIV prevention services; those in the peer support group were referred to peer navigators for health promotion, condom provision, and facilitation of attendance for differentiated HIV prevention services; and those in the final group received a combination of sexual and reproductive health services and peer support. Coprimary outcomes were linkage to clinical services within 60 days of enrolment, proportion of participants who had sexually transmissible HIV at 12 months after enrolment, and proportion of sampled individuals who consented to participation and gave a dried blood spot for HIV testing at 12 months. Logistic regression was used for analyses, and adjusted for age, sex, and rural or peri-urban area of residence. This study is registered with ClinicalTrials.gov (NCT04532307) and is closed. FINDINGS: Between March 2, 2020, and July 7, 2022, 1743 (75·7%) of 2301 eligible individuals were enrolled and followed up. 12-month dried blood spots were collected from 1168 participants (67·0%). The median age of the participants was 21 years (IQR 18-25), 51·4% were female, and 51·1% had secondary level education. Baseline characteristics and 12-month outcome ascertainment were similar between groups. 755 (43·3%) linked to services by 60 days. 430 (49·8%) of 863 who were in the sexual reproductive health services group were linked to care compared with 325 (36·9%) of 880 who were not in the sexual and reproductive health services group (adjusted odds ratio [aOR] 1·68; 95% CI 1·39-2·04); peer support had no effect: 385 (43·5%) of 858 compared with 370 (43·1%) of 885 (1·02, 0·84-1·23). At 12 months, 227 (19%) tested ELISA-positive for HIV, of whom 41 (18%) had viral loads of 400 copies per mL; overall prevalence of transmissible HIV was 3·5%. 22 (3·7%) of 578 participants in the sexual and reproductive health services group had transmissible HIV compared with 19 (3·3%) of 590 not in the sexual and reproductive health services group (aOR 1·12; 95% CI 0·60-2·11). The findings were also non-significant for peer support: 21 (3·3%) of 565 compared with 20 (3·3%) of 603 (aOR 1·03; 95% CI 0·55-1·94). There were no serious adverse events or deaths during the study. INTERPRETATION: This study provides evidence that STI testing and sexual and reproductive health services create demand for serostatus neutral HIV prevention in adolescents and young adults in Africa. STI testing and integration of HIV and sexual health has the potential to reach those at risk and tackle unmet sexual health needs. FUNDING: US National Institute of Health, Bill & Melinda Gates Foundation, and 3ie.

Increasing HIV testing and linkage to care among men in rural South Africa using conditional financial incentives and a decision support app: A process evaluation.

Men in sub-Saharan Africa are less likely to accept HIV testing and link to HIV care than women. We conducted a trial to investigate the impact of conditional financial incentives and a decision support application, called EPIC-HIV, on HIV testing and linkage to care. We report the findings of the trial process evaluation to explore whether the interventions were delivered as intended, identify mechanisms of impact and any contextual factors that may have impacted the trial outcomes. Between August 2018 and March 2019, we conducted in-depth interviews and focus group discussions with trial participants (n = 31) and staff (n = 14) to examine views on the implementation process, participant responses to the interventions and the external factors that may have impacted the implementation and outcomes of the study. Interviews were audio-recorded, transcribed, and translated where necessary, and thematically analyzed using ATLAS-ti and NVivo. Both interventions were perceived to be acceptable and useful by participants and implementers. EPIC-HIV proved challenging to implement as intended because it was difficult to ensure consistent use of earphones, and maintenance of privacy. Some participants struggled to navigate the EPIC-HIV app independently and select stories that appealed to them without support. Some participants stopped exploring the app before the end, resulting in an incomplete use of EPIC-HIV. While the financial incentive was implemented as intended, there were challenges with eligibility. The convenience and privacy of home testing influenced the uptake of HIV testing. Contextual barriers including fear of HIV stigma and disclosure if diagnosed with HIV, and expectations of poor treatment in clinics may have inhibited linkage to care. Financial incentives were relatively straightforward to implement and increased uptake of home-based rapid HIV testing but were not sufficient as a 'stand-alone' intervention. Barriers like fear of stigma should be addressed to facilitate linkage to care.

Violence outcomes in later adolescence with the Good School Toolkit-Primary: a nonrandomized controlled trial in Uganda.

BACKGROUND: We sought to determine whether the Good School Toolkit-Primary violence prevention intervention was associated with reduced victimisation and perpetration of peer and intimate partner violence four years later, and if any associations were moderated by sex and early adolescent: family connectedness, socio-economic status, and experience of violence outside of school. METHODS: Drawing on schools involved in a randomised controlled trial of the intervention, we used a quasi-experimental design to compare violence outcomes between those who received the intervention during our trial (n = 1388), and those who did not receive the intervention during or after the trial (n = 522). Data were collected in 2014 (mean age 13.4, SD 1.5 years) from participants in 42 schools in Luwero District, Uganda, and 2018/19 from the same participants both in and out of school (mean age 18, SD: 1.77 years). We compared children who received the Good School Toolkit-Primary, a whole school violence prevention intervention, during a randomised controlled trial, to those who did not receive the intervention during or after the trial. Outcomes were measured using items adapted from the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. We used mixed-effect multivariable logistic regression, with school fitted as a random-effect to account for clustering. RESULTS: 1910 adolescents aged about 16-19 years old were included in our analysis. We found no evidence of an average long-term intervention effect on our primary outcome, peer violence victimization at follow-up (aOR = 0.81, 95%CI = 0.59-1.11); or for any secondary outcome. However, exposure to the intervention was associated with: later reductions in peer violence, for adolescents with high family connectedness (aOR = 0.70, 95% CI 0.49 to 0.99), but not for those with low family connectedness (aOR = 1.07, 95% CI 0.69 to 1.6; p-interaction = 0.06); and reduced later intimate partner violence perpetration among males with high socio-economic status (aOR = 0.32, 95%CI 0.11 to 0.90), but not low socio-economic status (aOR = 1.01 95%CI 0.37 to 2.76, p-interaction = 0.05). CONCLUSIONS: Young adolescents in connected families and with higher socio-economic status may be better equipped to transfer violence prevention skills from primary school to new relationships as they get older. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01678846, registration date 24 August 2012. Protocol for this paper:  https://www.researchprotocols.org/2020/12/e20940 .

Understanding the contexts in which female sex workers sell sex in Kampala, Uganda: a qualitative study.

BACKGROUND: Structural, interpersonal and individual level factors can present barriers for HIV prevention behaviour among people at high risk of HIV acquisition, including women who sell sex. In this paper we document the contexts in which women selling sex in Kampala meet and provide services to their clients. METHODS: We collected qualitative data using semi-structured interviews. Women were eligible to participate if they were 18 years or older, self-identified as sex workers or offered sex for money and spoke Luganda or English. Ten women who met clients in venues and outdoor locations were selected randomly from a clinic for women at high risk of HIV acquisition. Ten other women who met clients online were recruited using snowball sampling. Interviews included demographic data, and themes included reasons for joining and leaving sex work, work locations, nature of relationships with clients and peers, interaction with authorities, regulations on sex work, and reported stigma. We conducted interviews over three months. Data were analysed thematically using a framework analysis approach. The coding framework was based on structural factors identified from literature, but also modified inductively with themes arising from the interviews. RESULTS: Women met clients in physical and virtual spaces. Physical spaces included venues and outdoor locations, and virtual spaces were online platforms like social media applications and websites. Of the 20 women included, 12 used online platforms to meet clients. Generally, women from the clinic sample were less educated and predominantly unmarried, while those from the snowball sample had more education, had professional jobs, or were university students. Women from both samples reported experiences of stigma, violence from clients and authorities, and challenges accessing health care services due to the illegality of sex work. Even though all participants worked in settings where sex work was illegal and consequently endured harsh treatment, those from the snowball sample faced additional threats of cybersecurity attacks, extortion from clients, and high levels of violence from clients. CONCLUSIONS: To reduce risk of HIV acquisition among women who sell sex, researchers and implementers should consider these differences in contexts, challenges, and risks to design innovative interventions and programs that reach and include all women.

Gendered risks: access to and utilization of sexual and reproductive health services among young migrants in Southwestern Uganda: the role of the 'lending a hand' intervention.

Introduction: Young migrants may engage in risky behaviours due to social, economic, and psychological challenges as they try to "get by" in their new host communities. This can result in unintended pregnancies, sexually transmitted infections including HIV, and poor mental health outcomes.During a study to test the feasibility and acceptability of an early intervention to reduce the harm of patterns of risk associated with migration, we assessed access to and utilization of sexual and reproductive health services (SRH) among recent migrants (14-24 years) in south-western Uganda. Methods: The intervention conducted in 2022/23 involved training peer supporters to provide referral advice and support to young people. Between March-November 2022, 20 young migrants (11 males and 9 females) were purposively selected to participate in two in-depth interviews each to explore their experiences during the intervention. Data were analysed thematically. Results: Women engaged in transactional sex to supplement their low pay while men got involved in risky behaviour once they had earned some money. Many suffered from sexually transmitted infections-related symptoms, were at risk for HIV infection and some women had fears of unwanted pregnancy. While some tried to seek for SRH services from public facilities, poor health service delivery such as long queues and shortages of drugs, discouraged them from going there. Young people tried to access treatment from private facilities but could not afford the costs. The intervention increased knowledge about SRH and supported young people to access services from the public health facilities at no cost thus increasing utilization. Conclusion: Sexual health risks were experienced differently by women and men. The women were likely to experience symptoms related to sexually transmitted infections (including HIV) much earlier than men and this could increase their likelihood to engage with SRH services. The intervention served to increase men's readiness to access SRH services by providing them at a time and place that is convenient. Recognizing the different risk profiles of young people is important in tailoring appropriate interventions to promote equitable access and utilization of SRH services for both genders in this vulnerable population.

Peer support for people living with hepatitis B virus-A foundation for treatment expansion.

Chronic hepatitis B infection (CHB) affects 300 million people worldwide and is being targeted by the United Nations 2030 Sustainable Development Goals (SDGs) and the World Health Organisation (WHO), working towards elimination of hepatitis B virus (HBV) as a public health threat. In this piece, we explore the evidence and potential impact of peer support to enhance and promote interventions for people living with CHB. Peer support workers (PSWs) are those with lived experience of an infection, condition or situation who work to provide support for others, aiming to improve education, prevention, treatment and other clinical interventions and to reduce the physical, psychological and social impacts of disease. Peer support has been shown to be a valuable tool for improving health outcomes for people living with human immunodeficiency virus (HIV) and hepatitis C virus (HCV), but to date has not been widely available for communities affected by HBV. HBV disproportionately affects vulnerable and marginalised populations, who could benefit from PSWs to help them navigate complicated systems and provide advocacy, tackle stigma, improve education and representation, and optimise access to treatment and continuity of care. The scale up of peer support must provide structured and supportive career pathways for PSWs, account for social and cultural needs of different communities, adapt to differing healthcare systems and provide flexibility in approaches to care. Investment in peer support for people living with CHB could increase diagnosis, improve retention in care, and support design and roll out of interventions that can contribute to global elimination goals.

Structural and social factors affecting COVID-19 vaccine uptake among healthcare workers and older people in Uganda: A qualitative analysis.

The COVID-19 vaccine rollout programme in Uganda was launched in March 2021 for priority groups: Healthcare Workers (HCWs), older persons (≥50 years), and persons with chronic conditions. Misinformation, distrust in healthcare systems, and cultural beliefs, pose significant challenges to vaccine uptake. We describe the social and structural factors affecting the uptake of COVID-19 vaccines among HCWs and older people in Uganda. Between September and October 2021, we conducted 33 in-depth interviews with 25 HCWs aged 21-63 years from three hospitals in central Uganda and eight older people from Wakiso district. Participant selection was purposive, based on sex, occupation, education, cadre of HCWs and vaccination status. We explored participants' knowledge, beliefs, personal experiences, barriers, and facilitators to vaccine uptake as well as suggestions for future COVID-19 vaccine rollout. Interviews were audio-recorded, transcribed and translated into English, coded, and analysed by theme. Twenty-two of the 25 (88%) HCWs and 3 of the 8 (38%) older people had received at least one dose of the COVID-19 vaccine at the time of interview. The structural facilitating factors to vaccine uptake included access to correct information, fear of a risky work environment, and mandatory vaccination requirements especially for frontline HCWs. Age, chronic health conditions, and the fear of death were facilitating factors for older people. Misconceptions about COVID-19 vaccines and fear of side effects were common social barriers for both groups. Long distances to vaccination centres, vaccine stock-outs, and long queues at the vaccination centres were specific barriers for older people. The prerequisite of signing a consent form was a specific structural barrier for HCWs. Future roll out of new vaccines should have a comprehensive information dissemination strategy about the vaccines. Improved access to vaccines through community outreach, reliable vaccine supplies and addressing vaccine misinformation, may enhance COVID-19 vaccine uptake.

Population impacts of conditional financial incentives and a male-targeted digital decision support application on the HIV treatment cascade in rural KwaZulu Natal: findings from the HITS cluster randomized clinical trial.

INTRODUCTION: In South Africa, the HIV care cascade remains suboptimal. We investigated the impact of small conditional financial incentives (CFIs) and male-targeted HIV-specific decision-support application (EPIC-HIV) on the HIV care cascade. METHODS: In 2018, in uMkhanyakude district, 45 communities were randomly assigned to one of four arms: (i) CFI for home-based HIV testing and linkage to care within 6 weeks (R50 [US$3] food voucher each); (ii) EPIC-HIV which are based on self-determination theory; (iii) both CFI and EPIC-HIV; and (iv) standard of care. EPIC-HIV consisted of two components: EPIC-HIV 1, provided to men through a tablet before home-based HIV testing, and EPIC-HIV 2, offered 1 month later to men who tested positive but had not yet linked to care. Linking HITS trial data to national antiretroviral treatment (ART) programme data and HIV surveillance programme data, we estimated HIV status awareness after the HITS trial implementation, ART status 3 month after the trial and viral load suppression 1 year later. Analysis included all known individuals living with HIV in the study area including those who did not participated in the HITS trial. RESULTS: Among the 33,778 residents in the study area, 2763 men and 7266 women were identified as living with HIV by the end of the intervention period and included in the analysis. After the intervention, awareness of HIV-positive status was higher in the CFI arms compared to non-CFI arms (men: 793/908 [87.3%] vs. 1574/1855 [84.9%], RR = 1.03 [95% CI: 0.99-1.07]; women: 2259/2421 [93.3%] vs. 4439/4845 [91.6%], RR = 1.02 [95% CI: 1.00-1.04]). Three months after the intervention, no differences were found for linkage to ART between arms. One year after the intervention, only 1829 viral test results were retrieved. Viral suppression was higher but not significant in the EPIC-HIV intervention arms among men (65/99 [65.7%] vs. 182/308 [59.1%], RR = 1.11 [95% CI: 0.88-1.40]). CONCLUSIONS: Small CFIs can contribute to achieve the first step of the HIV care cascade. However, neither CFIs nor EPIC-HIV was sufficient to increase the number of people on ART. Additional evidence is needed to confirm the impact of EPIC-HIV on viral suppression.

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study.

BACKGROUND: The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial. METHODS: We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken. RESULTS: Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged. CONCLUSION: We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.

Uptake of multi-level HIV interventions and HIV-related behaviours among young people in rural South Africa.

Combination HIV prevention packages have reduced HIV incidence and improved HIV-related outcomes among young people. However, there is limited data on how package components interact to promote HIV-related prevention behaviours. We described the uptake of HIV prevention interventions supported by Determined, Resilient, Empowered, AIDS-free, Motivated and Safe (DREAMS) Partnership and assessed the association between uptake and HIV-related behaviours among young people in rural KwaZulu-Natal, South Africa. We analysed two cohorts followed from May 2017 to December 2019 to evaluate the impact of DREAMS, covering 13-29 year-old females, and 13-35 year-old males. DREAMS interventions were categorised as healthcare-based or social. We described the uptake of interventions and ran logistic regression models to investigate the association between intervention uptake and subsequent protective HIV-related outcomes including no condomless sex and voluntary medical male circumcision (VMMC). For each outcome, we adjusted for socio-demographics and sexual/pregnancy history and reported adjusted odds ratios (aOR) and 95% confidence intervals (CI). Among 5248 participants, uptake of healthcare interventions increased from 2018 to 2019 by 8.1% and 3.7% for males and females respectively; about half of participants reported receiving both healthcare and social interventions each year. The most utilised combinations of interventions included HIV testing and counselling, school-based HIV education and cash transfers. Participation in social interventions only compared to no intervention was associated with reduced condomless sex (aOR = 1.60, 95%CI: 1.03-2.47), while participation in healthcare interventions only was associated with increased condomless sex. The uptake of interventions did not significantly affect subsequent VMMC overall. Among adolescent boys, exposure to school-based HIV education, cash transfers and HIV testing and counselling was associated with increase in VMMC (aOR = 1.79, 95%CI: 1.04-3.07). Multi-level HIV prevention interventions were associated with an increase in protective HIV-related behaviours emphasizing the importance of accessible programs within both school and community settings for young people.

A scoping review of ethics review processes during public health emergencies in Africa.

BACKGROUND: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Gender Differences in Social Support Vary by Environment Among Older People With HIV in South Africa and Uganda.

Background and Objectives: Sub-Saharan Africa is home to 3.7 million older adults living with HIV, who experience high rates of comorbid conditions. Formal services other than HIV clinical care are largely unavailable. Overall, women are the mainstay of informal social support networks, and older women with HIV may face burdens due to family caregiving expectations. Thus, it is important to understand the extent of informal support provided to older adults living with HIV, and how this is affected by gender. Research Design and Methods: We examined differences in social networks, needs, social support and caregiving, and perceptions of support adequacy among women and men aged 50 and older living with HIV in Uganda (n = 101) and South Africa (n = 108), mostly rural and suburban populations, respectively. We used multiple regression to determine whether there was an association between gender and the amount of social support received and whether that varied by research site. Results: Men were more likely than women to receive support from a partner. Women were more likely to live with offspring, both providing and receiving care. In South Africa but not Uganda, women received more help from family than men did. There was no gender difference in getting help from friends, but it was more common in Uganda. Living alone was strongly associated with less family help and more help from friends. Discussion and Implications: Older women with HIV in sub-Saharan Africa tend to be more heavily involved in social support exchanges-both providing and receiving care-than their male peers, but place matters. Interdependence is high in rural Uganda, where formal services are scarce and needs exceed resources. Given the projected growth in this population, stronger formal supports are needed for communities and older people with HIV, especially those who live alone.

The impact of a conditional financial incentive on linkage to HIV care: Findings from the HITS cluster randomized clinical trial in rural South Africa.

Introduction: HIV elimination requires innovative approaches to ensure testing and immediate treatment provision. We investigated the effectiveness of conditional financial incentives on increasing linkage to HIV care in a 2×2 factorial cluster randomized controlled trial-Home-Based Intervention to Test and Start (HITS) - in rural South Africa. Methods: Of 45 communities in uMkhanyakude, KwaZulu-Natal, 16 communities were randomly assigned to the arms to receive financial incentives for home-based HIV counseling and testing (HBHCT) and linkage to care within 6 weeks (R50 [US$3] food voucher each) and 29 communities to the arms without financial incentives. We examined linkage to care (i.e., initiation or resumption of antiretroviral therapy after >3 months of care interruption) at local clinics within 6 weeks of a home visit, the eligibility period to receive the second financial incentive. Linkage to care was ascertained from individual clinical records. Intention-to-treat analysis (ITT) was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., male-targeted HIV-specific decision support app) and clustering of standard errors at the community level. Results: Among 13,894 eligible men (i.e., ≥15 years and resident in the 45 communities), 20.7% received HBHCT, which resulted in 122 HIV-positive tests. Of these, 27 linked to care within 6 weeks of HBHCT. Additionally, of eligible men who did not receive HBHCT, 66 linked to care. In the ITT analysis, the proportion of linkage to care among men did not differ in the arms which received financial incentives and those without financial incentives (adjusted Risk Ratio [aRR]=0.78, 95% CI: 0.51-1.21). Among 19,884 eligible women, 29.1% received HBHCT, which resulted in 375 HIV-positive tests. Of these, 75 linked to care. Among eligible women who did not receive HBHCT, 121 linked to care within 6 weeks. Women in the financial incentive arms had a significantly higher probability of linkage to care, compared to those in the arms without financial incentives (aRR=1.50; 95% CI: 1.03-2.21). Conclusion: While a small once-off financial incentive did not increase linkage to care among men during the eligibility period of 6 weeks, it significantly improved linkage to care among women over the same period. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

Perceptions, attitudes, and willingness of healthcare and frontline workers to participate in an Ebola vaccine trial in Uganda.

BACKGROUND: Understanding the knowledge, perception and attitudes towards Ebola vaccines is an important factor in ensuring future use of these vaccines. A qualitative methods study embedded in an Ebola vaccine immunogenicity and safety trial (NCT04028349) was conducted to explore the knowledge and perceptions of healthcare (HCWs) and frontline workers (FLWs), about Ebola vaccines and their willingness to participate or recommend participation in Uganda. METHOD: We carried out focus group discussions and semi-structured interviews before and after vaccination, with 70 HCWs and FLWs who consented to participate in the trial, and in the qualitative component, from August to September 2019. Data were analysed using thematic content analysis. RESULTS: Respondents showed good knowledge about Ebola and the vaccines in general, and had wide access to information through several channels, including the study team. On prevention, particular attention was given to effective communication within health facilities. Misconceptions were mainly around route of transmission, animal origin and types of vaccines. Previous fears were based on rumours circulating in the community, mainly about the presence of the virus in the vaccine, side effects and intention to harm (e.g. by "the whites"), ultimately insisting on transparency, trust and involvement of local leaders. Acceptability of participation was motivated by the need to protect self and others, and the willingness to advance research. Majority were willing to recommend participation to their community. CONCLUSIONS: Overall, information sharing leads to a better understanding and acceptance of vaccine trials and a positive vaccination experience can be a deciding factor in the acceptance of others. Particular attention should be paid to involving the community in addressing misconceptions and fears, while ensuring that participants have access to vaccination sites in terms of transport, and that they are properly accommodated at the study site including staying for a reasonable period of time.

Effect of a male-targeted digital decision support application aimed at increasing linkage to HIV care among men: Findings from the HITS cluster randomized clinical trial in rural South Africa.

Introduction: Linkage to HIV care remains suboptimal among men. We investigated the effectiveness of a male-targeted HIV-specific decision support app, Empowering People through Informed Choices for HIV (EPIC-HIV), on increasing linkage to HIV care among men in rural South Africa. Methods: Home-Based Intervention to Test and Start (HITS) was a multi-component cluster-randomized controlled trial among 45 communities in uMkhanyakude, KwaZulu-Natal. The development of EPIC-HIV was guided by self-determination theory and human-centered intervention design to increase intrinsic motivation to seek HIV testing and care among men. EPIC-HIV was offered in two stages: EPIC-HIV 1 at the time of home-based HIV counseling and testing (HBHCT), and EPIC-HIV 2 at 1 month after positive HIV diagnosis. Sixteen communities were randomly assigned to the arms to receive EPIC-HIV, and 29 communities to the arms without EPIC-HIV. Among all eligible men, we compared linkage to care (initiation or resumption of antiretroviral therapy after >3 months of care interruption) at local clinics within 1 year of a home visit, which was ascertained from individual clinical records. Intention-to-treat analysis was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., financial incentives) and clustering at the community level. We also conducted a satisfaction survey for EPIC-HIV 2. Results: Among all 13,894 eligible men (i.e., ≥15 years and resident in the 45 communities), 20.7% received HBHCT, resulting in 122 HIV-positive tests. Among these, 54 men linked to care within 1 year after HBHCT. Additionally, of the 13,765 eligible participants who did not receive HBHCT or received HIV-negative results, 301 men linked to care within 1 year. Overall, only 13 men received EPIC-HIV 2. The proportion of linkage to care did not differ in the arms assigned to EPIC-HIV compared to those without EPIC-HIV (adjusted risk ratio=1.05; 95% CI:0.86-1.29). All 13 men who used EPIC-HIV 2 reported the app was acceptable, user-friendly, and useful for getting information on HIV testing and treatment. Conclusion: Reach was low although acceptability and usability of the app was very high among those who engaged with it. Enhanced digital support applications could form part of interventions to increase knowledge of HIV treatment for men. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

Scoping review on lessons learnt on the promotion and use of drugs and traditional medicine in Africa during COVID-19.

ABSTRACTScientific evidence on the safety and efficacy of pharmaceutical drugs, substances and herbal medicines is important in medical advertising and promotion. Following guidelines for conducting a scoping review, we systematically searched PubMed, SCOPUS and Web of Science to identify in peer reviewed articles medications that were promoted and used widely in Africa during the COVID-19 pandemic. We also searched for information about how safety concerns about untested/or not properly tested drugs were communicated to the public during the pandemic. Of the 2043 articles identified, 41 papers were eligible for inclusion. Most studies were clinical trials (n = 11), systematic reviews (n = 9), quantitative studies (n = 9) the rest were qualitative studies, reviews and reports. We found that following global trends, several drugs, traditional and herbal treatments were used and repurposed for the treatment of respiratory symptoms of COVID-19 in Africa. The results highlighted the value of some herbal medicines for treatment during the COVID-19 pandemic, as well as the risks posed by the unregulated sharing of advice and recommendations on treatments in Africa, and globally.

The HIV Empowering Adults' Decisions to Share: UK/Uganda (HEADS-UP) Study-A Randomised Feasibility Trial of an HIV Disclosure Intervention for Young Adults with Perinatally Acquired HIV.

Young adults with perinatally acquired HIV (PAH) face numerous challenges, including antiretroviral therapy (ART) adherence, managing onward HIV transmission risks and maintaining wellbeing. Sharing one's HIV status with others (onward HIV disclosure) may assist with these challenges but this is difficult. We developed and tested the feasibility of an intervention to help HIV status sharing decision-making for young adults with PAH. The study used a randomised parallel group feasibility design with 18-25-year-olds in Uganda and 18-29 year-olds in the UK. Participants were randomly assigned to intervention or standard of care (SOC) condition. The intervention consisted of four sessions (3 group, 1 individual) with follow-up support, delivered in person in Uganda and remotely in the UK. Assessments were carried out at: Pre-intervention /baseline; Post-intervention (intervention group only); Six-month follow-up. 142 participants were recruited (94 Uganda, 48 UK; 89 female, 53 male). At six-month follow-up, 92/94 (98%) participants were retained in Uganda, 25/48 (52%) in the UK. Multivariate analysis of combined data from both countries, showed a non-significant effect of intervention condition on HIV disclosure cognitions and affect (p = 0.08) and HIV disclosure intention (p = 0.09). There was a significant intervention effect on well-being (p = 0.005). This study addressed important gaps in understanding acceptable and feasible ways of delivering HIV status sharing support for young people living with PAH across two very different settings. The intervention was acceptable in both countries and feasible in Uganda. In the UK, retention may have been affected by its remote delivery.Trial registration: ISRCTN Registry, ISRCTN31852047, Registered on 21 January 2019.

HIV, Social Networks, and Loneliness among Older Adults in Uganda.

Loneliness among older adults has been identified as a major public health problem. Yet little is known about loneliness, or the potential role of social networks in explaining loneliness, among older people with HIV (PWH) in sub-Saharan Africa, where 70% of PWH reside. To explore this issue, we analyzed data from 599 participants enrolled in the Quality of Life and Ageing with HIV in Rural Uganda study, including older adults with HIV in ambulatory care and a comparator group of people without HIV of similar age and gender. The 3-item UCLA Loneliness Scale was used to measure loneliness, and HIV status was the primary explanatory variable. The study found no statistically significant correlation between loneliness and HIV status. However, individuals with HIV had smaller households, less physical and financial support, and were less socially integrated compared to those without HIV. In multivariable logistic regressions, loneliness was more likely among individuals who lived alone (aOR:3.38, 95% CI:1.47-7.76) and less likely among those who were married (aOR:0.34, 95% CI:0.22-0.53) and had a higher level of social integration (aOR:0.86, 95% CI: 0.79-0.92). Despite having smaller social networks and less support, older adults with HIV had similar levels of loneliness as those without HIV, which may be attributed to resiliency and access to HIV-related health services among individuals with HIV. Nonetheless, further research is necessary to better understand the mechanisms involved.