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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Use of HIV and HSV-2 biomarkers in sub-saharan adolescent prevention research: a comparison of two approaches.

Self-report of sexual behavior among adolescents is notoriously inconsistent, yet such measures are commonly used as outcomes for human immunodeficiency virus (HIV) prevention intervention trials. There has been a growing interest in the use of HIV and other sexually transmitted disease biomarkers as more valid measures of intervention impact in high HIV prevalence areas, particularly in sub-Saharan Africa. We examine the challenges, benefits, and feasibility of including HIV and herpes simplex virus type 2 (HSV-2) biomarker data, with details about different data collection and disclosure methods from two adolescent prevention trials in Kenya and Zimbabwe. In Kenya, whole blood samples were collected using venipuncture; adult guardians were present during biomarker procedures and test results were disclosed to participants and their guardians. In contrast, in Zimbabwe, samples were collected using finger pricks for dried blood spots (DBS); guardians were not present during biomarker procedures, and results were not disclosed to participants and/or their guardians. In both countries, prevalence in the study samples was low. Although the standard of care for testing for HIV and other sexually transmitted infections includes disclosure in the presence of a guardian for adolescents under age 18, we conclude that more research about the risks and benefits of disclosure to adolescents in the context of a clinical trial is needed. Notably, current serological diagnosis for HSV-2 has a low positive predictive value when prevalence is low, resulting in an unacceptable proportion of false positives and serious concerns about disclosing test results to adolescents within a trial. We also conclude that the DBS approach is more convenient and efficient than venipuncture for field research, although both approaches are feasible. Manufacturer validation studies using DBS for HSV-2, however, are needed for widespread use.

Preventing HIV by providing support for orphan girls to stay in school: does religion matter?

OBJECTIVE: The paper examines the influence of religion on attitudes, behaviors, and HIV infection among rural adolescent women in Zimbabwe. DESIGN: We analyzed data from a 2007 to 2010 randomized controlled trial in rural eastern Zimbabwe testing whether school support can prevent HIV risk behaviors and related attitudes among rural adolescent orphan girls; supplementary data from the 2006 Zimbabwe Demographic and Health Survey (ZDHS) were also analyzed. The present study design is largely cross-sectional, using the most recent available survey data from the clinical trial to examine the association between religious affiliation and religiosity on school dropout, marriage, and related attitudes, controlling for intervention condition, age and orphan type. The ZDHS data examined the effect of religious denomination on marriage and HIV status among young rural women, controlling for age. RESULTS: Apostolic Church affiliation greatly increased the likelihood of early marriage compared to reference Methodist Church affiliation (odds ratio = 4.5). Greater religiosity independently reduced the likelihood of school dropout, increased gender equity attitudes and disagreement with early sex, and marginally reduced early marriage. Young rural Apostolic women in the ZDHS were nearly four times as likely to marry as teenagers compared to Protestants, and marriage doubled the likelihood of HIV infection. CONCLUSIONS: Findings contradict an earlier seminal study that Apostolics are relatively protected from HIV compared to other Christian denominations. Young Apostolic women are at increased risk of HIV infection through early marriage. The Apostolic Church is a large and growing denomination in sub-Saharan Africa and many Apostolic sects discourage medical testing and treatment in favor of faith healing. Since this can increase the risk of undiagnosed HIV infection for young married women and their infants in high prevalence areas, further study is urgently needed to confirm this emerging public health problem, particularly among orphan girls. Although empirical evidence suggests that keeping orphan girls in school can reduce HIV risk factors, further study of the religious context and the implications for prevention are needed.

Cost-effectiveness of school support for orphan girls to prevent HIV infection in Zimbabwe.

This cost-effectiveness study analyzes the cost per quality-adjusted life year (QALY) gained in a randomized controlled trial that tested school support as a structural intervention to prevent HIV risk factors among Zimbabwe orphan girl adolescents. The intervention significantly reduced early marriage, increased years of schooling completed, and increased health-related quality of life. By reducing early marriage, the literature suggests the intervention reduced HIV infection. The intervention yielded an estimated US$1,472 in societal benefits and an estimated gain of 0.36 QALYs per orphan supported. It cost an estimated US$6/QALY gained, about 1 % of annual per capita income in Zimbabwe. That is well below the maximum price that the World Health Organization (WHO) Commission on Macroeconomics and Health recommends paying for health gains in low and middle income countries. About half the girls in the intervention condition were boarded when they reached high school. For non-boarders, the intervention's financial benefits exceeded its costs, yielding an estimated net cost savings of $502 per pupil. Without boarding, the intervention would yield net savings even if it were 34 % less effective in replication. Boarding was not cost-effective. It cost an additional $1,234 per girl boarded (over the 3 years of the study, discounted to present value at a 3 % discount rate) but had no effect on any of the outcome measures relative to girls in the treatment group who did not board. For girls who did not board, the average cost of approximately 3 years of school support was US$973.

Process and outcome evaluation of a community intervention for orphan adolescents in western Kenya.

We conducted a 2-year pilot randomized controlled trial (N = 105) in a high HIV-prevalence area in rural western Kenya to test whether providing young orphan adolescents with uniforms, school fees, and community visitors improves school retention and reduces HIV risk factors. The trial was a community intervention, limited to one community. In this paper, we examined intervention implementation and its association with outcomes using longitudinal data. We used both quantitative and qualitative methods to evaluate the community-based model for orphan HIV prevention, with recommendations for future studies. Despite promising effects after 1 year, GEE analyses showed null effects after 2 years. Volunteer community visitors, a key element of the intervention, showed little of the expected effect although qualitative reports documented active assistance to prevent orphans' school absence. For future research, we recommend capturing the transition to high school, a larger sample size, and biomarker data to add strength to the research design. We also recommend a school-based intervention approach to improve implementation and reduce infrastructure costs. Finally, we recommend evaluating nurses as agents for improving school attendance and preventing dropout because of their unique ability to address critical biopsychosocial problems.

Supporting adolescent orphan girls to stay in school as HIV risk prevention: evidence from a randomized controlled trial in Zimbabwe.

OBJECTIVES: Using a randomized controlled trial in rural eastern Zimbabwe, we tested whether comprehensive support to keep orphan adolescent girls in school could reduce HIV risk. METHODS: All orphan girls in grade 6 in 25 primary schools were invited to participate in the study in fall 2007 (n = 329). Primary schools were randomized to condition. All primary schools received a universal daily feeding program; intervention participants received fees, uniforms, and a school-based helper to monitor attendance and resolve problems. We conducted annual surveys and collected additional information on school dropout, marriage, and pregnancy rates. We analyzed data using generalized estimating equations over 3 time points, controlling for school and age at baseline. RESULTS: The intervention reduced school dropout by 82% and marriage by 63% after 2 years. Compared with control participants, the intervention group reported greater school bonding, better future expectations, more equitable gender attitudes, and more concerns about the consequences of sex. CONCLUSIONS: We found promising evidence that comprehensive school support may reduce HIV risk for orphan girls. Further study, including assessment of dose response, cost benefit, and HIV and herpes simplex virus 2 biomarker measurement, is warranted.

Apostolic faith church organization contexts for health and wellbeing in women and children.

OBJECTIVE: The study explored contexts for health and wellbeing for women and children influenced by the structural behavior of an Apostolic faith church organization in Zimbabwe. METHODS: Twenty-three purposively selected members of an African indigenous Apostolic church (males = 12; females = 11; age range 22-95 years) were informants to a focus group discussion session. They provided data on the institutional behaviors that were culturally-historically embedded in the organization's activities. Data were analyzed thematically and using cultural-historical activity theory (CHAT) to foreground essential themes. RESULTS: The church organization provided social capital to support health and wellbeing in members. However, the culturally embedded practices to minimize decision making by women and child members potentially compromised their health and wellbeing. CONCLUSION: The findings suggest that the structural activities of the church for health and wellbeing could also have the paradoxical effect of exposing women and children to health risks from obligatory roles.

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.