Do community measures impact the effectiveness of a community led HIV testing intervention. Secondary analysis of an HIV self-testing intervention in rural communities in Zimbabwe.

BACKGROUND: There is a growing body of evidence for the role that communities can have in producing beneficial health outcomes. There is also an increasing recognition of the effectiveness and success of community-led interventions to promote public health efforts. This study investigated whether and how community-level measures facilitate a community-led intervention to achieve improved HIV outcomes. METHODS: This is a secondary analysis of survey data from a cluster randomised trial in 40 rural communities in Zimbabwe. The survey was conducted four months after the intervention was initiated. Communities were randomised 1:1 to either paid distribution arm, where HIV self-test (HIVST) kits were distributed by a paid distributor, or community-led whereby members of the community were responsible for organising and conducting the distribution of HIVST kits. We used mixed effects logistic regression to assess the effect of social cohesion, problem solving, and HIV awareness on HIV testing and prevention. RESULTS: We found no association between community measures and the three HIV outcomes (self-testing, new HIV diagnosis and linkage to VMMC or confirmatory testing). However, the interaction analyses highlighted that in high social cohesion communities, the odds of new HIV diagnosis was greater in the community-led arm than paid distribution arm (OR 2.06 95% CI 1.03-4.19). CONCLUSION: We found some evidence that community-led interventions reached more undiagnosed people living with HIV in places with high social cohesion. Additional research should seek to understand whether the effect of social cohesion is persistent across other community interventions and outcomes. TRIAL REGISTRATION: PACTR201607001701788.

Preferences for oral-fluid-based or blood-based HIV self-testing and provider-delivered testing: an observational study among different populations in Zimbabwe.

BACKGROUND: There is limited data on client preferences for different HIV self-testing (HIVST) and provider-delivered testing options and associated factors. We explored client preferences for oral-fluid-based self-testing (OFBST), blood-based self-testing (BBST) and provider-delivered blood-based testing (PDBBT) among different populations. METHODS: At clinics providing HIV testing services to general populations (1 urban, 1 rural clinic), men seeking voluntary medical male circumcision (VMMC, 1 clinic), and female sex workers (FSW, 1 clinic), clients had the option to test using OFBST, BBST or PDBBT. A pre-test questionnaire collected information on demographics and testing history. Two weeks after collecting a self-test kit, participants responded to a questionnaire. We used logistic regression to determine predictors of choices. We also conducted 20 in-depth interviews to contextualise quantitative findings. RESULTS: May to June 2019, we recruited 1244 participants of whom 249 (20%), 251 (20%), 244 (20%) and 500 (40%) were attending urban general, rural, VMMC and FSW clinics, respectively. Half (n = 619, 50%) chose OFBST, 440 (35%) and 185 (15%) chose BBST and PDBBT, respectively. In multivariable analysis comparing those choosing HIVST (OFBST and BBST combined) versus not, those who had never married aOR 0.57 (95% CI 0.34-0.93) and those previously married aOR0.56 (0.34-0.93) were less likely versus married participants to choose HIVST. HIVST preference increased with education, aOR 2.00 (1.28-3.13), 2.55 (1.28-5.07), 2.76 (1.48-5.14) for ordinary, advanced and tertiary education, respectively versus none/primary education. HIVST preference decreased with age aOR 0.97 (0.96-0.99). Urban participants were more likely than rural ones to choose HIVST, aOR 9.77 (5.47-17.41), 3.38 (2.03-5.62) and 2.23 (1.38-3.61) for FSW, urban general and VMMC clients, respectively. Comparing those choosing OFBST with those choosing BBST, less literate participants were less likely to choose oral fluid tests, aOR 0.29 (0.09-0.92). CONCLUSIONS: Most testing clients opted for OFBST, followed by BBST and lastly, PDBBT. Those who self-assessed as less healthy were more likely to opt for PDBBT which likely facilitated linkage. Results show importance of continued provision of all strategies in order to meet needs of different populations, and may be useful to inform both HIVST kit stock projections and tailoring of HIVST programs to meet the needs of different populations.

Delivery of index-linked HIV testing for children: learnings from a qualitative process evaluation of the B-GAP study in Zimbabwe.

BACKGROUND: Index-linked HIV testing for children, whereby HIV testing is offered to children of individuals living with HIV, has the potential to identify children living with undiagnosed HIV. The "Bridging the Gap in HIV Testing and Care for Children in Zimbabwe" (B-GAP) study implemented and evaluated the provision of index-linked HIV testing for children aged 2-18 years in Zimbabwe. We conducted a process evaluation to understand the considerations for programmatic delivery and scale-up of this strategy. METHODS: We used implementation documentation to explore experiences of the field teams and project manager who delivered the index-linked testing program, and to describe barriers and facilitators to index-linked testing from their perspectives. Qualitative data were drawn from weekly logs maintained by the field teams, monthly project meeting minutes, the project coordinator's incident reports and WhatsApp group chats between the study team and the coordinator. Data from each of the sources was analysed thematically and synthesised to inform the scale-up of this intervention. RESULTS: Five main themes were identified related to the implementation of the intervention: (1) there was reduced clinic attendance of potentially eligible indexes due to community-based differentiated HIV care delivery and collection of HIV treatment by proxy individuals; (2) some indexes reported that they did not live in the same household as their children, reflecting the high levels of community mobility; (3) there were also thought to be some instances of 'soft refusal'; (4) further, delivery of HIV testing was limited by difficulties faced by indexes in attending health facilities with their children for clinic-based testing, stigma around community-based testing, and the lack of familiarity of indexes with caregiver provided oral HIV testing; (5) and finally, test kit stockouts and inadequate staffing also constrained delivery of index-linked HIV testing. CONCLUSIONS: There was attrition along the index-linked HIV testing cascade of children. While challenges remain at all levels of implementation, programmatic adaptations of index-linked HIV testing approaches to suit patterns of clinic attendance and household structures may strengthen implementation of this strategy. Our findings highlight the need to tailor index-linked HIV testing to subpopulations and contexts to maximise its effectiveness.

On Campus HIV Self-Testing Distribution at Tertiary Level Colleges in Zimbabwe Increases Access to HIV Testing for Youth.

PURPOSE: HIV self-testing allows youth to access testing outside of healthcare facilities. We investigated the feasibility of peer distribution of HIV self-testing (HIVST) kits to youth aged 16-24 years and examined the factors associated with testing off-site rather than at distribution points. METHODS: From July 2019 to March 2020, HIVST kits were distributed on 12 tertiary education campuses throughout Zimbabwe. Participants chose to test at the HIVST distribution point or off-site. Factors associated with choosing to test off-site and factors associated with reporting a self-test result for those who tested off-site were investigated using logistic regression. RESULTS: In total, 5,351 participants received an HIVST kit, over 129 days, of whom 3,319 (62%) tested off-site. The median age of recipients was 21 years (interquartile range 20-23); 64% were female. Overall, 2,933 (55%) returned results, 23 (1%) of which were reactive. Being female (adjusted odds ratio [aOR] 1.16, 95% confidence interval [CI] 1.03-1.31), living on campus (aOR 1.24, 95% CI 1.09-1.40), used a condom at last sex (aOR 1.44, 95% CI 1.26-1.65), and previous knowledge of HIVST (aOR 1.22, 95% CI 1.09-1.37) were associated with off-site testing. Attending a vocational college and teachers training college compared to a university was associated with choosing to return results for those who tested off-site (OR 2.40, 95% CI 1.65-3.48, p < .001). DISCUSSION: HIVST distribution is an effective method of reaching a large number of youth over a short period of time. Efforts to increase awareness and roll out of HIVST on campuses should be coupled with support for linkage to HIV prevention and treatment services.

When healthcare providers are supportive, 'I'd rather not test alone': Exploring uptake and acceptability of HIV self-testing for youth in Zimbabwe - A mixed method study.

INTRODUCTION: In sub-Saharan Africa, less than half of young people know their HIV status. HIV self-testing (HIVST) is a testing strategy with the potential to offer privacy and autonomy. We aimed to understand the uptake and acceptability of different HIV testing options for youth in Harare, Zimbabwe. METHODS: This study was nested within a cluster randomized trial of a youth-friendly community-based integrated HIV and sexual and reproductive health intervention for youth aged 16-24 years. Three HIV testing options were offered: (1) provider-delivered testing; (2) HIVST on site in a private booth without a provider present; and (3) provision of a test kit to test off site. Descriptive statistics and proportions were used to investigate the uptake of HIV testing in a client sample. A focus group discussion (FGD) with intervention providers alongside in-depth interviews, paired interviews and FGDs with a selected sample of youth clients explored uptake and acceptability of the different HIV testing strategies. Thematic analysis was used to analyse the qualitative data. RESULTS: Between April and June 2019, 951 eligible clients were tested for HIV: 898 (94.4%) chose option 1, 30 (3.25%) chose option 2 and 23 (2.4%) chose option 3. Option 1 clients cited their trust in the service and a desire for immediate counselling, support and guidance from trusted providers as the reasons for their choice. Young people were not confident in their expertise to conduct HIVST. Concerns about limited privacy, confidentiality and lack of support in the event of an HIV-positive result were barriers for off-site HIVST. CONCLUSIONS: In the context of supportive, trusted and youth-friendly providers, youth clients overwhelmingly preferred provider-delivered HIV testing over client-initiated HIVST or HIVST off site. This highlights the importance of listening to youth to improve engagement in testing. While young people want autonomy in choosing when, where and how to test, they do not want to necessarily test on their own. They desire quality in-person counselling, guidance and support, alongside privacy and confidentiality. To increase the appeal of HIVST for youth, greater provision of access to private spaces is required, and accessible pre- and post-test counselling and support may improve uptake.

Comparison of community-led distribution of HIV self-tests kits with distribution by paid distributors: a cluster randomised trial in rural Zimbabwean communities.

BACKGROUND: We compared community-led versus an established community-based HIV self-testing (HIVST) model in rural Zimbabwe using a cluster-randomised trial. METHODS: Forty village groups were randomised 1:1 using restricted randomisation to community-led HIVST, where communities planned and implemented HIVST distribution for 4 weeks, or paid distribution (PD), where distributors were paid US$50 to distribute kits door-to-door over 4 weeks. Individual level primary outcomes compared household survey responses by arm 4 months post-intervention for: (1) newly diagnosed HIV during/within 4 months following HIVST distribution, (2) linkage to confirmatory testing, pre-exposure prophylaxis or voluntary medical male circumcision during/within 4 months following HIVST distribution. Participants were not masked to allocation; analysis used masked data. Trial analysis used random-effects logistic regression.Distribution costs compared: (1) community-led HIVST, (2) PD HIVST and (3) PD costs when first implemented in 2016/2017. RESULTS: From October 2018 to August 2019, 27 812 and 36 699 HIVST kits were distributed in community-led and PD communities, respectively. We surveyed 11 150 participants and 5683 were in community-led arm. New HIV diagnosis was reported by 211 (3.7%) community-led versus 197 (3.6%) PD arm participants, adjusted OR (aOR) 1.1 (95% CI 0.72 to 1.56); 318 (25.9%) community-led arm participants linked to post-test services versus 361 (23.9%) in PD arm, aOR 1.1 (95% CI 0.75 to 1.49.Cost per HIVST kit distributed was US$6.29 and US$10.25 for PD and community-led HIVST, both lower than 2016/2017 costs for newly implemented PD (US$14.52). No social harms were reported. CONCLUSIONS: Community-led HIVST can perform as well as paid distribution, with lower costs in the first year. These costs may reduce with programme maturity/learning. TRIAL REGISTRATION NUMBER: PACTR201811849455568.

Feasibility and Accuracy of HIV Testing of Children by Caregivers Using Oral Mucosal Transudate HIV Tests.

BACKGROUND: Children encounter multiple barriers in accessing facilities. HIV self-testing using oral mucosal transudate (OMT) tests has been shown to be effective in reaching hard-to-reach populations. We evaluated the feasibility and accuracy of caregivers conducting HIV testing using OMTs in children in Zimbabwe. METHODS: We offered OMTs to caregivers (>18 years) living with HIV to test children (2-18 years) living in their households. All caregivers were provided with manufacturer instructions. In Phase 1 (January-December 2018, 9 clinics), caregivers additionally received a demonstration by a provider using a test kit and video. In Phase 2 (January-May 2019, 3 clinics), caregivers did not receive a demonstration. We collected demographic data and assessed caregiver's ability to perform the test and interpret results. Caregiver performance was assessed by direct observation and scored using a predefined checklist. Factors associated with obtaining a full score were analyzed using logistic regression. RESULTS: Overall 400 caregivers (83.0% female, median age 38 years) who were observed tested 786 children (54.6% female, median age 8 years). For most tests, caregivers correctly collected oral fluid [87.1% without provider demonstrations (n = 629) and 96.8% with demonstrations (n = 157), P = 0.002]. The majority correctly used a timer (90.3% without demonstrations and 96.8% with demonstrations, P = 0.02). In multivariate logistic regression caregivers who obtained a full score for performance were more likely to have received a demonstration (odds ratio 4.14, 95% confidence interval: 2.01 to 8.50). CONCLUSIONS: Caregiver-provided testing using OMTs is a feasible and accurate HIV testing strategy for children. We recommend operational research to support implementation at scale.

Comparison of index-linked HIV testing for children and adolescents in health facility and community settings in Zimbabwe: findings from the interventional B-GAP study.

BACKGROUND: Index-linked HIV testing, whereby children of individuals with HIV are targeted for testing, increases HIV yield but relies on uptake. Community-based testing might address barriers to testing access. In the Bridging the Gap in HIV testing and care for children in Zimbabwe (B-GAP) study, we investigated the uptake and yield of index-linked testing in children and the uptake of community-based vs facility-based HIV testing in Zimbabwe. METHODS: B-GAP was an interventional study done in the city of Bulawayo and the province of Matabeleland South between Jan 29 and Dec 12, 2018. All HIV-positive attendees (index patients) at six urban and three rural primary health-care clinics were offered facility-based or community-based HIV testing for children (age 2-18 years) living in their households who had never been tested or had tested as HIV-negative more than 6 months ago. Community-based options involved testing in the home by either a trained lay worker with a blood-based rapid diagnostic test (used in facility-based testing), or by the child's caregiver with an oral HIV test. Among consenting individuals, the primary outcome was testing uptake in terms of the proportion of eligible children tested. Secondary outcomes were uptake of the different HIV testing methods, HIV yield (proportion of eligible children who tested positive), and HIV prevalence (proportion of HIV-positive children among those tested). Logistic regression adjusting for within-index clustering was used to investigate index patient and child characteristics associated with testing uptake, and the uptake of community-based versus facility-based testing. FINDINGS: Overall, 2870 index patients were linked with 6062 eligible children (3115 [51·4%] girls [sex unknown in seven], median age 8 years [IQR 5-13]). Testing was accepted by index patients for 5326 (87·9%) children, and 3638 were tested with a known test outcome, giving an overall testing uptake among 6062 eligible children of 60·0%. 39 children tested positive for HIV, giving an HIV prevalence among the 3638 children of 1·1% and an HIV yield among 6062 eligible children of 0·6%. Uptake was positively associated with female sex in the index patient (adjusted odds ratio [aOR] 1·56 [95% CI 1·38-1·77], p<0·0001) and child (aOR 1·10 [1·03-1·19], p=0·0080), and negatively associated with any financial cost of travel to a clinic (aOR 0·86 [0·83-0·88], p<0·0001), increased child age (6-9 years: aOR 0·99 (0·89-1·09); 10-15 years: aOR 0·91 [0·83-1·00]; and 16-18 years: aOR 0·75 [0·66-0·85]; p=0·0001 vs 2-5 years), and unknown HIV status of the mother (aOR 0·81 [0·68-0·98], p=0·027 vs HIV-positive status). Additionally, children had increased odds of being tested if community-based testing was chosen over facility-based testing at screening (1320 [73·9%] children tested of 1787 vs 2318 [65·5%] of 3539; aOR 1·49 [1·22-1·81], p=0·0001). INTERPRETATION: The HIV yield of index-linked testing was low compared with blanket testing approaches in similar settings. Index-linked HIV testing can improve testing uptake among children, although strategies that improve testing uptake in older children are needed. Community based testing by lay workers is a feasible strategy that can be used to improve uptake of HTS among children and adolescents. FUNDING: UK Medical Research Council, UK Department for International Development, Wellcome Trust.

Use and awareness of and willingness to self-test for HIV: an analysis of cross-sectional population-based surveys in Malawi and Zimbabwe.

BACKGROUND: Many southern African countries are nearing the global goal of diagnosing 90% of people with HIV by 2020. In 2016, 84 and 86% of people with HIV knew their status in Malawi and Zimbabwe, respectively. However, gaps remain, particularly among men. We investigated awareness and use of, and willingness to self-test for HIV and explored sociodemographic associations before large-scale implementation. METHODS: We pooled responses from two of the first cross-sectional Demographic and Health Surveys to include HIV self-testing (HIVST) questions in Malawi and Zimbabwe in 2015-16. We investigated sociodemographic factors and sexual risk behaviours associated with previously testing for HIV, and past use, awareness of, and future willingness to self-test using univariable and multivariable logistic regression, adjusting for the sample design and limiting analysis to participants with a completed questionnaire and valid HIV test result. We restricted analysis of willingness to self-test to Zimbabwean men, as women and Malawians were not systematically asked this question. RESULTS: Of 31,385 individuals, 31.2% of men had never tested compared with 16.5% of women (p < 0.001). For men, the likelihood of having ever tested increased with age. Past use and awareness of HIVST was very low, 1.2 and 12.6%, respectively. Awareness was lower among women than men (9.1% vs 15.3%, adjusted odds ratio [aOR] = 1.55; 95% confidence interval [CI]: 1.37-1.75), and at younger ages, and lower education and literacy levels. Willingness to self-test among Zimbabwean men was high (84.5%), with greater willingness associated with having previously tested for HIV, being at high sexual risk (highest willingness [aOR = 3.74; 95%CI: 1.39-10.03, p < 0.009]), and being ≥25 years old. Wealthier men had greater awareness of HIVST than poorer men (p < 0.001). The highest willingness to self-test (aOR = 3.74; 95%CI: 1.39-10.03, p < 0.009) was among men at high HIV-related sexual risk. CONCLUSIONS: In 2015-16, many Malawian and Zimbabwean men had never tested for HIV. Despite low awareness and minimal HIVST experience, willingness to self-test was high among Zimbabwean men, especially older men with moderate-to-high HIV-related sexual risk. These data provide a valuable baseline against which to investigate population-level uptake of HIVST as programmes scale up. Programmes introducing, or planning to introduce, HIVST should consider including relevant questions in population-based surveys.

The impact and cost-effectiveness of community-based HIV self-testing in sub-Saharan Africa: a health economic and modelling analysis.

INTRODUCTION: The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost-effectiveness of community-based HIV self-testing (CB-HIVST) is unclear. We aimed to assess this in different sub-populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub-Saharan Africa. METHODS: The synthesis model was used to address this aim. Three sub-populations were considered for CB-HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB-HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB-HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five-year time-limited CB-HIVST programme. Cost-effectiveness was defined by an incremental cost-effectiveness ratio (ICER; cost-per-disability-adjusted life-year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB-HIVST was evaluated using the number of additional tests per infection or death averted. RESULTS: In the base case, targeting adult men with CB-HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost-effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB-HIVST to WTS was the most cost-effective. The main drivers of cost-effectiveness were the cost of CB-HIVST and the prevalence of undiagnosed HIV. All other CB-HIVST scenarios had an ICER above US$500 per DALY averted. CONCLUSIONS: CB-HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB-HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub-population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost-effectiveness.

Economic cost analysis of door-to-door community-based distribution of HIV self-test kits in Malawi, Zambia and Zimbabwe.

INTRODUCTION: HIV self-testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder-to-reach populations. This study provides the first empirical evidence of the costs of door-to-door community-based HIVST distribution in Malawi, Zambia and Zimbabwe. METHODS: HIVST kits were distributed door-to-door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on-site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start-up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. RESULTS: In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site-level fixed costs. Site-level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. CONCLUSIONS: These early door-to-door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale-up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers' costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door-to-door community-led distribution to reach end-users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

The Self-Testing AfRica (STAR) Initiative: accelerating global access and scale-up of HIV self-testing.

INTRODUCTION: HIV self-testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the "HIV Self-Testing AfRica (STAR) Initiative," HIVST remained unexplored with negligible access in low- and middle-income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale-up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. DISCUSSION: The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic-based distribution to workplace and partner-delivered approaches to reach first-time male testers, to community outreach to sex workers and general population "hotspots." These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additional testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end-November 2018 several quality-assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre-qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. CONCLUSIONS: The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale-up based on the wealth of multi-country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost-effective means to expand access to treatment and prevention services.

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe. METHODS: The first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed. CONCLUSIONS: Active surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13-17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

Counseling Received by Adolescents Undergoing Voluntary Medical Male Circumcision: Moving Toward Age-Equitable Comprehensive Human Immunodeficiency Virus Prevention Measures.

Background: The minimum package of voluntary medical male circumcision (VMMC) services, as defined by the World Health Organization, includes human immunodeficiency virus (HIV) testing, HIV prevention counseling, screening/treatment for sexually transmitted infections, condom promotion, and the VMMC procedure. The current study aimed to assess whether adolescents received these key elements. Methods: Quantitative surveys were conducted among male adolescents aged 10-19 years (n = 1293) seeking VMMC in South Africa, Tanzania, and Zimbabwe. We used a summative index score of 8 self-reported binary items to measure receipt of important elements of the World Health Organization-recommended HIV minimum package and the US President's Emergency Plan for AIDS Relief VMMC recommendations. Counseling sessions were observed for a subset of adolescents (n = 44). To evaluate factors associated with counseling content, we used Poisson regression models with generalized estimating equations and robust variance estimation. Results: Although counseling included VMMC benefits, little attention was paid to risks, including how to identify complications, what to do if they arise, and why avoiding sex and masturbation could prevent complications. Overall, older adolescents (aged 15-19 years) reported receiving more items in the recommended minimum package than younger adolescents (aged 10-14 years; adjusted ß, 0.17; 95% confidence interval [CI], .12-.21; P < .001). Older adolescents were also more likely to report receiving HIV test education and promotion (42.7% vs 29.5%; adjusted prevalence ratio [aPR], 1.53; 95% CI, 1.16-2.02) and a condom demonstration with condoms to take home (16.8% vs 4.4%; aPR, 2.44; 95% CI, 1.30-4.58). No significant age differences appeared in reports of explanations of VMMC risks and benefits or uptake of HIV testing. These self-reported findings were confirmed during counseling observations. Conclusions: Moving toward age-equitable HIV prevention services during adolescent VMMC likely requires standardizing counseling content, as there are significant age differences in HIV prevention content received by adolescents.

Community burden of undiagnosed HIV infection among adolescents in Zimbabwe following primary healthcare-based provider-initiated HIV testing and counselling: A cross-sectional survey.

BACKGROUND: Children living with HIV who are not diagnosed in infancy often remain undiagnosed until they present with advanced disease. Provider-initiated testing and counselling (PITC) in health facilities is recommended for high-HIV-prevalence settings, but it is unclear whether this approach is sufficient to achieve universal coverage of HIV testing. We aimed to investigate the change in community burden of undiagnosed HIV infection among older children and adolescents following implementation of PITC in Harare, Zimbabwe. METHODS AND FINDINGS: Over the course of 2 years (January 2013-January 2015), 7 primary health clinics (PHCs) in southwestern Harare implemented optimised, opt-out PITC for all attendees aged 6-15 years. In February 2015-December 2015, we conducted a representative cross-sectional survey of 8-17-year-olds living in the 7 communities served by the study PHCs, who would have had 2 years of exposure to PITC. Knowledge of HIV status was ascertained through a caregiver questionnaire, and anonymised HIV testing was carried out using oral mucosal transudate (OMT) tests. After 1 participant taking antiretroviral therapy was observed to have a false negative OMT result, from July 2015 urine samples were obtained from all participants providing OMTs and tested for antiretroviral drugs to confirm HIV status. Children who tested positive through PITC were identified from among survey participants using gender, birthdate, and location. Of 7,146 children in 4,251 eligible households, 5,486 (76.8%) children in 3,397 households agreed to participate in the survey, and 141 were HIV positive. HIV prevalence was 2.6% (95% CI 2.2%-3.1%), and over a third of participants with HIV were undiagnosed (37.7%; 95% CI 29.8%-46.2%). Similarly, among the subsample of 2,643 (48.2%) participants with a urine test result, 34.7% of those living with HIV were undiagnosed (95% CI 23.5%-47.9%). Based on extrapolation from the survey sample to the community, we estimated that PITC over 2 years identified between 18% and 42% of previously undiagnosed children in the community. The main limitation is that prevalence of undiagnosed HIV was defined using a combination of 3 measures (OMT, self-report, and urine test), none of which were perfect. CONCLUSIONS: Facility-based approaches are inadequate in achieving universal coverage of HIV testing among older children and adolescents. Alternative, community-based approaches are required to meet the Joint United Nations Programme on HIV/AIDS (UNAIDS) target of diagnosing 90% of those living with HIV by 2020 in this age group.

Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe. METHODS: The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal. CONCLUSIONS: Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.

Employing Demand-Based Volumetric Forecasting to Identify Potential for and Roles of Devices in Scale-Up of Medical Male Circumcision in Zambia and Zimbabwe.

INTRODUCTION: Devices for male circumcision (MC) are becoming available in 14 priority countries where MC is being implemented for HIV prevention. Understanding potential impact on demand for services is one important programmatic consideration because countries determine whether to scale up devices within MC programs. METHODS: A population-based survey measuring willingness to undergo MC, assuming availability of surgical MC and 3 devices, was conducted among 1250 uncircumcised men, ages 10-49 years in Zambia and 1000 uncircumcised men, ages 13-49 years in Zimbabwe. Simulated Test Market methodology was used to estimate incremental MC demand and the extent to which devices might be preferred over surgery, assuming availability of: surgical MC in both countries; the devices PrePex, ShangRing, and Unicirc in Zambia; and PrePex in Zimbabwe. RESULTS: Modeled estimates indicate PrePex has the potential to provide an overall increase in MC demand ranging from an estimated 13%-50%, depending on country and WHO prequalification ages, replacing 11%-41% of surgical procedures. In Zambia, ShangRing could provide 8% overall increase, replacing 45% of surgical procedures, and Unicirc could provide 30% overall increase, replacing 85% of surgical procedures. CONCLUSIONS: In both countries, devices have potential to increase overall demand for MC, assuming wide scale awareness and availability of circumcision by the devices. With consideration for age and country, PrePex may provide the greatest potential increase in demand, followed by Unicirc (measured in Zambia only) and ShangRing (also Zambia only). These results inform one program dimension for decision making on potential device introduction strategies; however, they must be considered within the broader programmatic context.

Implementation and Operational Research: The Effectiveness of Routine Opt-Out HIV Testing for Children in Harare, Zimbabwe.

OBJECTIVE: HIV testing is the entry point to access HIV care. For HIV-infected children who survive infancy undiagnosed, diagnosis usually occurs on presentation to health care services. We investigated the effectiveness of routine opt-out HIV testing (ROOT) compared with conventional opt-in provider-initiated testing and counseling (PITC) for children attending primary care clinics. METHODS: After an evaluation of PITC services for children aged 6-15 years in 6 primary health care facilities in Harare, Zimbabwe, ROOT was introduced through a combination of interventions. The change in the proportion of eligible children offered and receiving HIV tests, reasons for not testing, and yield of HIV-positive diagnoses were compared between the 2 HIV testing strategies. Adjusted risk ratios for having an HIV test in the ROOT compared with the PITC period were calculated. RESULTS: There were 2831 and 7842 children eligible for HIV testing before and after the introduction of ROOT. The proportion of eligible children offered testing increased from 76% to 93% and test uptake improved from 71% to 95% in the ROOT compared with the PITC period. The yield of HIV diagnoses increased from 2.9% to 4.5%, and a child attending the clinics post intervention had a 1.99 increased adjusted risk (95% CI: 1.85 to 2.14) of receiving an HIV test in the ROOT period compared with the preintervention period. CONCLUSION: ROOT increased the proportion of children undergoing HIV testing, resulting in an overall increased yield of positive diagnoses, compared with PITC. ROOT provides an effective approach to reduce missed HIV diagnosis in this age group.

Positive attitudes to pediatric HIV testing: findings from a nationally representative survey from Zimbabwe.

OBJECTIVE: Early HIV testing and diagnosis are paramount for increasing treatment initiation among children, necessary for their survival and improved health. However, uptake of pediatric HIV testing is low in high-prevalence areas. We present data on attitudes towards pediatric testing from a nationally representative survey in Zimbabwe. METHODS: All 18-24 year olds and a proportion of 25-49 year olds living in randomly selected enumeration areas from all ten Zimbabwe provinces were invited to self-complete an anonymous questionnaire on a personal digital assistant, and 16,719 people agreed to participate (75% of eligibles). RESULTS: Most people think children can benefit from HIV testing (91%), 81% of people who looked after children know how to access testing for their children and 92% would feel happier if their children were tested. Notably, 42% fear that, if tested, children may be discriminated against by some community members and 28% fear their children are HIV positive. People who fear discrimination against children who have tested for HIV are more likely than their counterparts to perceive their community as stigmatizing against HIV positive people (43% vs. 29%). They are also less likely to report positive attitudes to HIV themselves (49% vs. 74%). Only 28% think it is possible for children HIV-infected at birth to live into adolescence without treatment. Approximately 70% of people (irrespective of whether they are themselves parents) think HIV-infected children in their communities can access testing and treatment. CONCLUSIONS: Pediatric HIV testing is the essential gateway to prevention and care services. Our data indicate positive attitudes to testing children, suggesting a conducive environment for increasing uptake of pediatric testing in Zimbabwe. However, there is a need to better understand the barriers to pediatric testing, such as stigma and discrimination, and address the gaps in knowledge regarding HIV/AIDS in children.