The Ethics of Stigma in Medical Male Circumcision Initiatives Involving Adolescents in Sub-Saharan Africa.

Ongoing global efforts to circumcise adolescent and adult males to reduce their risk of acquiring HIV constitute the largest public health prevention initiative, using surgical means, in human history. Voluntary medical male circumcision (VMMC) programs in Africa have significantly altered social norms related to male circumcision among previously non-circumcising groups and groups that have practiced traditional (non-medical) circumcision. One consequence of this change is the stigmatization of males who, for whatever reason, remain uncircumcised. This paper discusses the ethics of stigma with regard to uncircumcised adolescent males in global VMMC programs, particularly in certain recruitment, demand creation and social norm interventions. Grounded in our own experiences gained while conducting HIV-related ethics research with adolescents in Kenya, we argue that use of explicit or implicit stigma to increase the number of VMMC volunteers is unethical from a public health ethics perspective, particularly in campaigns that leverage social norms of masculinity. Ongoing global efforts to circumcise adolescent and adult males to reduce their risk of acquiring HIV constitute the largest public health prevention initiative, using surgical means, in human history. VMMC programs in Africa have significantly altered social norms related to male circumcision among previously non-circumcising groups and groups that have practiced traditional (non-medical) circumcision. One consequence of this change is the stigmatization of males who, for whatever reason, remain uncircumcised. This paper discusses the ethics of stigma with regard to uncircumcised adolescent males in global VMMC programs, particularly in certain recruitment, demand creation and social norm interventions. Grounded in our own experiences gained while conducting HIV-related ethics research with adolescents in Kenya, we argue that use of explicit or implicit stigma to increase the number of VMMC volunteers is unethical from a public health ethics perspective, particularly in campaigns that leverage social norms of masculinity.

Ethics of pursuing targets in public health: the case of voluntary medical male circumcision for HIV-prevention programs in Kenya.

The use of targets to direct public health programmes, particularly in global initiatives, has become widely accepted and commonplace. This paper is an ethical analysis of the utilisation of targets in global public health using our fieldwork on and experiences with voluntary medical male circumcision (VMMC) initiatives in Kenya. Among the many countries involved in VMMC for HIV prevention, Kenya is considered a success story, its programmes having medically circumcised nearly 2 million men since 2007. We describe ethically problematic practices in Kenyan VMMC programmes revealed by our fieldwork, how the problems are related to the pursuit of targets and discuss possible approaches to their management. Although the establishment and pursuit of targets in public health can have many benefits, assessments of target-driven programmes tend to focus on quantifiable outcomes rather than the processes by which the outcomes are obtained. However, in order to speak more robustly about programmatic 'success', and to maintain community trust, it is vital to ethically evaluate how a public health initiative is actually implemented in the pursuit of its targets.

Voluntary medical male circumcision for HIV prevention among adolescents in Kenya: Unintended consequences of pursuing service-delivery targets.

INTRODUCTION: Voluntary medical male circumcision (VMMC) provides significant reductions in the risk of female-to-male HIV transmission. Since 2007, VMMC has been a key component of the United States President's Emergency Plan for AIDS Relief's (PEPFAR) strategy to mitigate the HIV epidemic in countries with high HIV prevalence and low circumcision rates. To ensure intended effects, PEPFAR sets ambitious annual circumcision targets and provides funding to implementation partners to deliver local VMMC services. In Kenya to date, 1.9 million males have been circumcised; in 2017, 60% of circumcisions were among 10-14-year-olds. We conducted a qualitative field study to learn more about VMMC program implementation in Kenya. METHODS AND RESULTS: The study setting was a region in Kenya with high HIV prevalence and low male circumcision rates. From March 2017 through April 2018, we carried out in-depth interviews with 29 VMMC stakeholders, including "mobilizers", HIV counselors, clinical providers, schoolteachers, and policy professionals. Additionally, we undertook observation sessions at 14 VMMC clinics while services were provided and observed mobilization activities at 13 community venues including, two schools, four public marketplaces, two fishing villages, and five inland villages. Analysis of interview transcripts and observation field notes revealed multiple unintended consequences linked to the pursuit of targets. Ebbs and flows in the availability of school-age youths together with the drive to meet targets may result in increased burdens on clinics, long waits for care, potentially misleading mobilization practices, and deviations from the standard of care. CONCLUSION: Our findings indicate shortcomings in the quality of procedures in VMMC programs in a low-resource setting, and more importantly, that the pursuit of ambitious public health targets may lead to compromised service delivery and protocol adherence. There is a need to develop improved or alternative systems to balance the goal of increasing service uptake with the responsible conduct of VMMC.

Consent Challenges and Psychosocial Distress in the Scale-up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya.

In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15-19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents' well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.

"If the mother does not know, there is no way she can tell the adolescent to go for drugs": Challenges in promoting health and preventing transmission among pregnant and parenting Kenyan adolescents living with HIV.

Adolescents living with HIV (ALHIV) who are pregnant, or parenting, are an important but understudied group. This study explores the challenges in promoting the health of these adolescents and preventing onward transmission. We used existing semi-structured interview data from a 2014 study conducted among Kenyan ALHIV (ages 15-19), their family members, and local health staff to examine adolescent HIV-testing, disclosure, and treatment engagement, focusing on participants who were pregnant, had given birth, or had fathered a child. A total of 28 participant interviews were analyzed, including those conducted with nine ALHIV, four family members, and 15 HIV providers. Four adolescent participants were not in care at the time of their interview. Our analysis also included a transcript from a stakeholder meeting involving HIV providers and associated administrators, held to disseminate and garner feedback on, preliminary findings from the original study. Based on our analysis, adolescents frequently reported being alone during testing, experiencing fear and denial on receiving their results, and delaying disclosure to family and linkage to treatment. They also mentioned a lack of contraceptive counseling, with some reporting multiple pregnancies. Providers voiced misgivings and uncertainty about disclosing HIV diagnoses to minor adolescents without a family member present and reported severe shortages of personnel and resources to adequately serve ALHIV in rural clinics. These findings highlight gaps in services that limit adolescent engagement in HIV treatment prior to sexual debut and conceiving a child, and in PMTCT during and after pregnancy. Greater research attention is needed to address ALHIV reproductive health needs, improve linkage to HIV treatment, and prevent onward sexual transmission. Empirical ethics studies of current adolescent disclosure policies are also warranted to examine cultural and developmental appropriateness, and effectiveness in fostering support and engagement in HIV services.

"I think the parent should be there because no one was born alone": Kenyan adolescents' perspectives on parental involvement in HIV research.

Despite a pressing need for adolescent HIV research in sub-Saharan Africa, ethical guidance for conducting research among minor adolescents is lacking. One ethical issue is the degree to which parents should be involved in the research process. The existing discourse is predominantly speculative and focuses on negative consequences of parental involvement. We use empirical data to describe the perspectives of Kenyan adolescents on parental involvement in consent and disclosure of HIV test results within a research study context. We conducted two rounds of focus group discussions with 40 adolescents in western Kenya to ask about minor adolescent participation in HIV research. We analysed data using codes and matrices. Kenyan adolescents were largely in favour of parental involvement during the research process. Half felt adolescent minors should solicit parental consent to participate, and nearly all said parents should learn the HIV test results of adolescent minors in order to provide necessary support. From their perspective, involvement of parents in research extends beyond obtaining their consent to providing essential support for youth, regardless of HIV status, both during and beyond the research study. Ethical guidelines that prioritise adolescent autonomy in research must consider reasons to involve parents considered important by adolescents themselves, particularly in low-resource settings.

An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study.

OBJECTIVE: To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. DESIGN: The adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English. SETTING: The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya. PARTICIPANTS: Twenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2-4 weeks after first questionnaire administration among 74 adolescents, young adults and parents. OUTCOME MEASURE: Primary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts. RESULTS: Ceiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability. CONCLUSIONS: Our study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension.

School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya.

PURPOSE: Using a clustered randomized controlled trial design, we evaluated whether support to keep Kenyan orphaned adolescents in school reduces the risk of HIV infection. METHODS: Participants included 835 orphaned boys and girls in grades 7 and 8 (mean age at the baseline = 15 years) in western Kenya. Primary schools (N = 26) were randomized to the study condition. Intervention participants received school uniforms, payment of tuition when they transitioned into high school, and nurse visits to monitor school absenteeism and provide assistance to stay in school. Annual surveys were conducted from 2011 through 2014, and HIV and herpes simplex virus 2 (HSV-2) biomarker data were collected at the baseline and the end line. Data were analyzed using survey logistic regression or generalized estimating equations controlling for age, gender, and socioeconomic status. RESULTS: Intervention and control groups were equivalent at the baseline and did not differ on new HIV or HSV-2 incidence at the end line. The school support intervention increased school retention but had few HIV-related effects, except increased circumcision among male participants and reduced likelihood of transactional sex. CONCLUSIONS: Despite a strong study design, we found no relative reduction in HIV or HSV-2 infection after 3 years of intervention implementation. New incidence of HIV was lower than expected in this region among youth whose average age at end line was 18 years (range = 14-23). Although support for secondary school promises many benefits for vulnerable youth, our study adds to the growing body of research showing weak evidence for its effectiveness as an HIV prevention.

Experiences along the HIV care continuum: perspectives of Kenyan adolescents and caregivers.

To be effective, HIV programmes should be responsive to the unique needs of diverse groups of infected adolescents. We highlight a range of adolescent perspectives on HIV services, including those who acquired HIV perinatally or sexually and those who were either in care, had dropped out of care, or had never enrolled in care. We conducted semi-structured interviews with 29 adolescents (aged 15-19) and 14 caregivers in western Kenya. Data were analysed using a descriptive analytical approach. Adolescents who were successfully linked had a supportive adult present during diagnosis; tested during hospitalisation or treatment for a recurrent or severe illness; and initiated treatment soon after diagnosis. Barriers to retention included side effects from HIV drugs, pill burden, and limited access to clean water and nutritious food. Support in family, school, and health facility environments was key for diagnosis, linkage, and retention. We make recommendations that may improve adolescent engagement in HIV services.

Process Evaluation of a Clinical Trial to Test School Support as HIV Prevention Among Orphaned Adolescents in Western Kenya.

Orphaned adolescents are a large and vulnerable population in sub-Saharan Africa, at higher risk for HIV than non-orphans. Yet prevention of new infection is critical for adolescents since they are less likely than adults to enter and remain in treatment and are the only age group with rising AIDS death rates. We report process evaluation for a randomized controlled trial (RCT) testing support to stay in school (tuition, uniform, nurse visits) as an HIV prevention strategy for orphaned Kenyan adolescents. The RCT found no intervention effect on HIV/HSV-2 biomarker outcomes. With process evaluation, we examined the extent to which intervention elements were implemented as intended among the intervention group (N = 412) over the 3-year study period (2012-2014), the implementation effects on school enrollment (0-9 terms), and whether more time in school impacted HIV/HSV-2. All analyses examined differences as a whole, and by gender. Findings indicate that school fees and uniforms were fully implemented in 94 and 96% of cases, respectively. On average, participants received 79% of the required nurse visits. Although better implementation of nurse visits predicted more terms in school, a number of terms did not predict the likelihood of HIV/HSV-2 infection. Attending boarding school also increased number of school terms, but reduced the odds of infection for boys only. Four previous RCTs have been conducted in sub-Saharan Africa, and only one found limited evidence of school impact on adolescent HIV/HSV-2 infection. Our findings add further indication that the association between school support and HIV/HSV-2 prevention appears to be weak or under-specified.

The Significance of Benefit Perceptions for the Ethics of HIV Research Involving Adolescents in Kenya.

Assessment of benefits is traditionally regarded as crucial to the ethical evaluation of research involving human participants. We conducted focus group discussions (FGDs) with health and other professionals engaged with adolescents, caregivers/parents, and adolescents in Siaya County, Kenya, to solicit opinions about appropriate ways of conducting HIV research with adolescents. Our data revealed that many focus group participants have a profoundly positive conception of participation in health research, including studies conferring seemingly few benefits. In this article, we identify and analyze five different but interrelated types of benefits as perceived by Kenyan adolescent and adult stakeholders in HIV research, and discuss their ethical significance. Our findings suggest that future empirical and conceptual research should concentrate on factors that may trigger researcher obligations to improve benefit perceptions among research participants.

Evaluation of Herpes Simplex Virus Type 2 Serological Tests for Use With Dried Blood Spots in Kenya.

We evaluated 2 assays to detect antibodies to herpes simplex virus type 2 in dried blood spots prepared from blood specimens submitted to a reference laboratory in Kenya. Dried blood spots did not perform well with the Kalon herpes simplex virus type 2 assay. Focus HerpeSelect 2 was 98.8% sensitive and 98.9% specific with dried blood spots.

Influence of school support on early marriage experiences and health services utilization among young orphaned women in Zimbabwe.

School support programs reduce school dropout, early marriage, and early pregnancy for a majority of young orphaned women. We used a mixed-methods approach to examine why these programs are less effective for a significant minority by exploring their influence on marriage and health services utilization. Participants were from a randomized controlled trial testing school support as HIV prevention. Half as many intervention as control participants had been married; married intervention participants had 1 more year of education compared with married control participants. Receiving school support did not appear to improve health-related factors. Pregnancy was among the most common reasons for marriage across both groups. The greatest benefit of school support appears to be in delaying marriage and pregnancy while increasing educational attainment.

'I thought if I marry the prophet I would not die': The significance of religious affiliation on marriage, HIV testing, and reproductive health practices among young married women in Zimbabwe.

This study examines the association between religious affiliation and reasons for marriage, perceived church attitudes, and reproductive health-seeking behaviors, including HIV testing, among young women in eastern rural Zimbabwe. The sample comprised women (N = 35) who had married by 2012 while participating in a larger randomized controlled trial (RCT) to test the effects of school support on HIV-related risk. The RCT sample was identified in 2007 as all female sixth graders in 25 rural eastern Zimbabwe primary schools whose parents, one or both, had died (N = 328). In our previous RCT analyses, we found that participants who affiliated with an Apostolic church were more than four times more likely to marry than those from non-Apostolic churches and that control group participants were twice as likely to marry as those in the intervention group. Other studies had found that marriage greatly increased the odds of HIV infection among adolescent women. Given the link between Apostolic affiliation and marriage, we conducted semi-structured interviews to explore type of marriage, reasons for marrying, church affiliation and attitudes, family planning, HIV testing, schooling, and family life. We were interested in differences, as perceived by our sample of young married women congregants, among Apostolic sects and other denominations in their attitudes about marriage and health-seeking behaviors. We were also interested in the influence of church affiliation on intervention participants' decision to marry, since they had comprehensive school support and education is highly valued in Zimbabwe, but costly and often out of financial reach. Interviews were conducted from October 2012 through November 2013; data were analyzed using a general inductive approach. We found that pressure or perceived deception for coitus or marriage was reported only by intervention participants affiliated with Apostolic denominations. Other reasons for marriage were similar between Apostolic and non-Apostolic adherents, as well as intervention and control conditions. All participants believed HIV testing was important, but while all non-Apostolic denominations encouraged HIV testing and clinic/hospital care, there was considerable heterogeneity in attitudes among Apostolics, with ultraconservative denominations most likely to proscribe non-religious health care. We conclude that some, but not all, Apostolic-affiliated women are afforded discretion in their health-seeking behaviors. Since HIV screening and treatment depend on access to clinic/hospital care, continued public health efforts to engage Apostolic leaders is needed, along with monitoring of progress in access and outcomes.

Marital Age Disparity Among Orphaned Young Women and Their Husbands: A Mixed Methods Study in Rural Zimbabwe.

Our study reports the results from a mixed method study comparing age-similar (AS) marriages of orphaned young women to age disparate (AD) marriages, defined as spousal age difference of 5 or more years. Research in Zimbabwe and sub-Saharan Africa suggests that AD sexual relationships between older men and young women increase the risk for HIV but few studies have examined this association among married couples or explored why young women marry much older men. In this study, a total of 35 orphaned young women aged 17-26 years in rural Zimbabwe participated in semi-structured interviews during 2012-2013. Twenty-four were in AD marriages and 11 AS. All had participated in a 5-year HIV prevention trial, during which they had married and dropped out of school. We examined two research questions: were AD wives more likely than AS to cite economic considerations as a reason to marry, and were AD marriages associated with different health and economic outcomes compared to AS? Our results showed that the reasons the women married were essentially the same among the two groups; economic considerations for marriage were uncommon. Nevertheless, AD wives generally fared somewhat better than AS wives on economic and well-being measures. HIV prevalence was similar; however, the AD group accounted for all five cases of herpes simplex virus-2. Findings suggest the complexity of sexual and reproductive health in rural Africa, where AD marriages are common and accepted. The challenge for primary prevention is to develop strategies to mitigate the risk of sexually transmitted infections, as well as the potential abuse of young women, within the appropriate cultural context.

Educational Outcomes for Orphan Girls in Rural Zimbabwe: Effects of a School Support Intervention.

Educational achievement has important implications for the health and well-being of young women in sub-Saharan Africa. The authors assessed the effects of providing school support on educational outcomes of orphan girls in rural Zimbabwe. Data were from a randomized controlled trial offering the intervention group comprehensive schooling support and controls no treatment initially and then fees only. Results indicated comprehensive support reduced school dropout and absence but did not improve test scores. Providing support to orphan girls is promising for addressing World Health Organization Millennium Development Goals, but further research is needed about contextual factors affecting girls' school participation and learning.

Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya.

OBJECTIVES: Herpes simplex virus type 2 (HSV-2) biomarkers are often used in adolescent sub-Saharan HIV prevention studies, but evaluations of test performance and disclosure outcomes are rare in the published literature. Therefore, we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot (WB), the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya. METHODS: In 2011, 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes. We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity; positive and indeterminate results were WB tested. We developed culturally sensitive protocols for disclosing positive results, and documented psychosocial responses, reports of sexual contact and HSV-2 symptoms. RESULTS: 28 adolescents (3.3%) were identified as HSV-2 seropositive, six as indeterminate. Of these, 22 positive and all indeterminates were WB tested; 20 and 5, respectively, were confirmed positive. Most youth reported moderate brief stress after disclosure; 22% reported longer and more severe distress. Boys were more likely to be in the latter category. Self-reported virginity was highly inconsistent with WB-confirmed positives. CONCLUSIONS: The higher than manufacturer's cut-off for Kalon ELISA modestly reduced the rate of false-positive test results, but also increased false negatives. Investigators should consider the risk:benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions. TRIAL REGISTRATION NUMBER: NCT01501864.

HIV infection and related risk behaviors: does school support level the playing field between orphans and nonorphans in Zimbabwe?

Research is limited on whether providing school support to female adolescent orphans mitigates their HIV risk disadvantage compared to other female adolescents. This paper examines 2011 Zimbabwe Demographic and Health Survey (ZDHS) HIV-related biomarker and behavior data for orphaned and nonorphaned rural adolescent females to compare findings from a similar sample participating in a randomized controlled trial (RCT) testing school support as HIV prevention. HIV status, marriage, pregnancy, sexual debut, school dropout, years of schooling, and socioeconomic status were analyzed with the combined data-sets. Bivariate analyses compared variables between RCT comprehensive intervention and delayed partial intervention conditions, and between ZDHS orphan and nonorphan groups. Multivariable analyses included a series of group comparisons as follows: ZDHS orphans vs. ZDHS nonorphans; RCT orphans in each condition vs. ZDHS nonorphans; RCT orphans in each condition vs. ZDHS orphans. Analyses methods accounted for the complex survey sampling design within each data-set. A total of 751 observations were included. All orphan groups had consistently higher odds of HIV infection than ZDHS nonorphans. ZDHS orphans had higher odds of marriage, pregnancy, and sexual debut than ZDHS nonorphans. Comprehensive intervention participants had lower odds of marriage, sexual debut, and school dropout than ZDHS nonorphans. RCT participants in both conditions had lower odds of marriage, sexual debut, and school dropout than ZDHS orphans. The findings indicate that orphans are at a distinct disadvantage to HIV risk compared to nonorphans, and much of this is likely related to vertical transmission. We found no evidence that provision of school fees to orphans will reduce their risk of HIV infection relative to nonorphans but further evidence that such programs may reduce risk behaviors including early sexual debut, child marriage, and school dropout. Further research is needed to determine how these programs can be sustainably scaled-up in resource-limited settings.

Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya.

BACKGROUND: This paper examines the discordance between biological data of HIV and herpes simplex virus type 2 (HSV-2) infections and self-reported questionnaire responses among orphan adolescents in Western Kenya. METHODS: In 2011, 837 orphan adolescents from 26 primary schools were enrolled in an HIV prevention trial. At baseline, blood samples were drawn for HIV and HSV-2 infection biomarker testing, and participants completed an audio computer-assisted self-interviewing survey. RESULTS: Comparing biological data with self-reported responses indicated that 70% of HIV-positive (7 out of 10) and 64% of HSV-2-positive (18 out of 28 positive) participants reported never having had sex. Among ever-married adolescents, 65% (57 out of 88) reported never having had sex. Overall, 10% of study participants appeared to have inconsistently reported their sexual behaviour. Logistic regression analyses indicated that lower educational level and exam scores were significant predictors of inconsistent reporting. CONCLUSIONS: Our study demonstrates the discordance between infections measured by biomarkers and self-reports of having had sex among orphan adolescents in Kenya. In order to detect programme effects accurately in prevention research, it is necessary to collect both baseline and endline biological data. Furthermore, it is recommended to triangulate multiple data sources about adolescent participants' self-reported information about marriage and pregnancies from school records and parent/guardians to verify the information. Researchers should recognise potential threats to validity in data and design surveys to consider cognitive factors and/or cultural context to obtain more accurate and reliable information from adolescents regarding HIV/sexually transmitted infection risk behaviours. CLINICAL TRAIL REGISTRATION NUMBER: NCT01501864.

The impact of school subsidies on HIV-related outcomes among adolescent female orphans.

PURPOSE: We examine effects of school support as a structural HIV prevention intervention for adolescent female orphans in Zimbabwe after 5 years. METHODS: Three hundred twenty-eight orphan adolescent girls were followed in a clustered randomized controlled trial from 2007 to 2010. The experimental group received school fees, uniforms, and school supplies and were assigned a school-based "helper." In 2011-2012, the control group received delayed partial treatment of school fees only. At the final data point in 2012, survey, HIV, and Herpes Simplex Virus Type 2 (HSV-2) biomarker data were collected from approximately 88% of the sample. Bivariate and multivariate analyses were conducted on end point outcomes, controlling for age, religious affiliation, and baseline socioeconomic status. RESULTS: The two groups did not differ on HIV or HSV-2 biomarkers. The comprehensive 5-year intervention continued to reduce the likelihood of marriage, improve school retention, improve socioeconomic status (food security), and marginally maintain gains in quality of life, even after providing school fees to the control group. CONCLUSIONS: Paying school fees and expenses resulted in significant improvements in life outcomes for orphan adolescent girls. Biological evidence of HIV infection prevention, however, was not observed. Our study adds to the growing body of research on school support as HIV prevention for girls in sub-Saharan Africa, but as yet, no clear picture of effectiveness has emerged.