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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

ABSTRACT: BACKGROUND:The HIV epidemic in Eastern and Southern Africa is characterized by a high incidence and prevalence of HIV infection among adolescent girls and young women (AGYW) aged 15-24 years. For instance, in some countries, HIV prevalence in AGYW aged 20-24 years exceeds that in AGYW aged 15-19 years by 2:1. Sauti (meaning voices), a project supported by the United States Agency for International Development, is providing HIV combination prevention interventions to AGYW in the Shinyanga region, Tanzania. OBJECTIVE:The aim of this study is to determine the impact of cash transfer on risky sexual behavior among AGYW receiving cash transfer and HIV combination prevention interventions. This paper describes the research methods and general protocol of the study. Risky sexual behavior will be assessed by herpes simplex virus type 2 (HSV-2) incidence, compensated sex (defined as sexual encounters motivated by exchange for money, material support, or other benefits), and intergenerational sex (defined as a sexual partnership between AGYW and a man 10 or more years older). Through a qualitative study, the study seeks to understand how the intervention affects the structural and behavioral drivers of the HIV epidemic. METHODS:The trial employs audio computer-assisted self-interviewing, participatory group discussions (PGDs), and case studies to collect data. A total of 30 matched villages (15 intervention and 15 control clusters) were randomized to either receive cash transfer delivered over 18 months in addition to other HIV interventions (intervention arm) or to receive other HIV interventions without cash transfer (control arm). Study participants are interviewed at baseline and 6, 12, and 18 months to collect data on demographics, factors related to HIV vulnerabilities, family planning, sexual risk behavior, gender-based violence, and HSV-2 and HIV infections. A total of 6 PGDs (3 intervention, 3 control) were conducted at baseline to describe perceptions and preferences of different intervention packages, whereas 20 case studies are used to monitor and unearth the dynamics involved in delivery and uptake of cash transfer. RESULTS:The study was funded in June 2017; enrollment took place in December 2017. A total of two rounds of the follow-up survey are complete, and one round has yet to be conducted. The results are expected in December 2019 and will be disseminated through conferences and peer-reviewed publications. CONCLUSIONS:This study will document the synergetic impact of cash transfer in the presence of HIV combination prevention interventions on risky sexual behavior among out-of-school AGYW. The results will strengthen the evidence of cash transfer in the reduction of risky sexual behavior and provide feasible HIV prevention strategies for AGYW. TRIAL REGISTRATION:Clinicaltrials.gov NCT03597243; https://clinicaltrials.gov/ct2/show/NCT03597243. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14696.

SUBMITTER: Wambura M

PROVIDER: S-EPMC6942193 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

Wambura Mwita M Drake Mary M Kuringe Evodius E Majani Esther E Nyato Daniel D Casalini Caterina C Materu Jacqueline J Mjungu Deusdedit D Nnko Soori S Mbita Gaspar G Kalage Esther E Shao Amani A Changalucha John J Komba Albert A

JMIR research protocols 20191220 12

<h4>Background</h4>The HIV epidemic in Eastern and Southern Africa is characterized by a high incidence and prevalence of HIV infection among adolescent girls and young women (AGYW) aged 15-24 years. For instance, in some countries, HIV prevalence in AGYW aged 20-24 years exceeds that in AGYW aged 15-19 years by 2:1. Sauti (meaning voices), a project supported by the United States Agency for International Development, is providing HIV combination prevention interventions to AGYW in the Shinyanga ...[more]

PMID: 31859686

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Project description:BackgroundPoverty and social inequality exacerbate HIV risk among adolescent girls and young women (AGYW) in sub-Saharan Africa. Cash transfers can influence the structural determinants of health, thereby reducing HIV risk.ObjectiveThis study assessed the effectiveness of cash transfer delivered along with combination HIV prevention (CHP) interventions in reducing the risky sexual behavior of AGYW in Tanzania. The incidence of herpes simplex virus type 2 (HSV-2) infection was used as a proxy for sexual risk behavior.MethodsA cluster randomized controlled trial was conducted in 15 matched pairs of communities (1:1 intervention to control) across 3 strata (urban, rural high-risk, and rural low-risk populations) of the Shinyanga Region, Tanzania. The target population was out-of-school AGYW aged 15-23 years who had completed 10-hour sessions of social and behavior change communication. Eligible communities were randomly assigned to receive CHP along with cash transfer quarterly (intervention group) or solely CHP interventions (control group) with no masking. Study recruitment and baseline survey were conducted between October 30, 2017 and December 1, 2017. Participants completed an audio computer-assisted self-interview, HIV counselling and testing, and HSV-2 testing at baseline and during follow-up visits at 6, 12, and 18 months after the baseline survey. A Cox proportional hazards model with random effects specified at the level of clusters (shared frailty) adjusted for matching pairs and other baseline imbalances was fitted to assess the effects of cash transfer on the incidence of HSV-2 infection (primary outcome). Secondary outcomes included HIV prevalence at follow-up, self-reported intergenerational sex, and self-reported compensated sex. All secondary outcomes were measured at each study visit.ResultsOf the 3026 AGYW enrolled in the trial (1482 in the intervention and 1544 in the control), 2720 AGYW (1373 in the intervention and 1347 in the control) were included in the final analysis. Overall, HSV-2 incidence was not significantly different at all follow-up points between the study arms in the adjusted analysis (hazard ratio 0.96, 95% CI 0.67-1.38; P=.83). However, HSV-2 incidence was significantly lower in the rural low-risk populations who received the cash transfer intervention (hazard ratio 0.45, 95% CI 0.29-0.71; P=.001), adjusted for potential confounders.ConclusionsAlthough this trial showed no significant impact of the cash transfer intervention on HSV-2 incidence among AGYW overall, the intervention significantly reduced HSV-2 incidence among AGYW in rural low-risk communities. Factors such as lesser poverty and more asset ownership in urban and rural high-risk communities may have undermined the impact of cash transfer.Trial registrationClinicalTrials.gov NCT03597243; https://clinicaltrials.gov/show/NCT03597243.

Project description:BackgroundTransactional sexual relationships contribute to a high incidence of HIV infection among adolescent girls and young women (AGYW) living in low-resource settings. Cash transfers (CT) are a structural approach to reduce sexual risk behaviors, but their positive economic effects frequently fade after the program ends. We aimed to understand AGYW's decision-making processes related to sexual, relationship, and financial decisions, in order to design a framework for a CT program that could lead to long-term financial independence and reduced transactional sex among AGYW.MethodsWe conducted qualitative research with AGYW participating in a CT program in Tanzania. Phase one was formative research to understand the context and experiences of AGYW regarding sexual behavior, relationships, and finances. Participants included 36 AGYW (15-23 years old), 15 influencers of AGYW (mothers and male partners) and 10 financially empowered women (FEW - women aged 20-30 with a sustained, reliable source of income independent of their partner). Decisions and decision-making contexts of AGYW that we identified in phase one informed the content of phase two. In phase two we simulated scenarios for decision-making and economic goals with 80 AGYW and 40 FEW, in order to identify key principles or intervention opportunities to guide development of a CT program framework.ResultsThrough phases one and two of our research we identified three key themes in AGYW's vision of their desired future economic state: 1) positive social image, 2) power balance and respect, and 3) emotional and economic security. An important theme distinguishing AGYW from FEW was that AGYW lacked a vision to build self-agency.ConclusionsOur findings suggest that providing economic resources to AGYW through CT without ensuring self-agency is unlikely to be an effective long-term intervention for economic empowerment. Using these findings we developed a framework for CT programs with three key pillars for developing self-agency: 1) emotional efficacy, to increase AGYW's perception of rewards associated with developing self-agency; 2) social efficacy, to build constructive relationships and exit negative relationships that inhibit self-agency, and 3) economic efficacy, to help AGYW build a resilient stream of financial resources.

Project description:BackgroundAge disparities in sexual relationships have been proposed as a key risk factor for HIV transmission in Sub-Saharan Africa, but evidence remains inconclusive. The SIHR study, a cluster randomised trial of a cash transfer programme in Malawi, found that young women in the intervention groups were less likely to have had a sexual partner aged 25 or older, and less likely to test positive for HIV and HSV-2 at follow-up compared to control groups. We examined the hypotheses that girls in the intervention groups had smaller age differences than control groups and that large age differences were associated with relationship-level HIV transmission risk factors: inconsistent condom use, sex frequency, and relationship duration.MethodsWe conducted an analysis of schoolgirls in the Schooling, Income, and Health Risk (SIHR) study aged 13-22 at baseline (n?=?2907). We investigated the effects of study arm, trial stage and participant age on age differences in sexual relationships using a linear mixed-effects model. Cumulative-link mixed-effects models were used to estimate the effect of relationship age difference on condom use and sex frequency, and a Cox proportional hazard model was used to estimate the effect of relationship age difference on relationship duration. We controlled for the girl's age, number of partners, study group and study round.ResultsGirls receiving cash transfers, on average, had smaller age differences in relationships compared to controls, though the estimated difference was not statistically significant (-?0.43 years; 95% CI: -1.03, 0.17). The older the participant was, the smaller her age differences (-?0.67 per 4-year increase in age; 95% CI: -0.99, -?0.35). Among controls, after the cash transfers had ended the average age difference was 0.82 years larger than during the intervention (95% CI: 0.43, 1.21), suggesting a possible indirect effect of the study on behaviour in the community as a whole. Across treatment groups, larger age differences in relationships were associated with lower levels of condom use, more frequent sex, and longer relationship durations.ConclusionsCash-transfer programmes may prevent HIV transmission in part by encouraging young women to form age-similar relationships, which are characterised by increased condom use and reduced sex frequency. The benefits of these programmes may extend to those who are not directly receiving the cash.

Project description:BackgroundHigh rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya.MethodsIn this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months. The CCT intervention comprised 1500KES (US$15 in 2016) via a cash card each school trimester. All four treatment groups received puberty and hygiene training. Assenting girls with parent or guardian consent who were post-menarche, not pregnant, area residents, not boarding, and had no disabilities precluding participation were eligible. Socio-behavioural risk factors and incidence of HIV and herpes simplex virus type 2 (HSV-2) were measured annually. School retainment and adverse events were monitored throughout. The primary outcome comprised a composite of incident HIV, HSV-2 and/or all-cause school dropout by school exit examination. The primary analysis was by intention-to-treat (ITT) using generalised linear mixed models, controlling for a priori selected baseline covariates. The trial is registered with ClinicalTrials.gov, NCT03051789.FindingsBetween February 28, 2017 and June 30, 2021, 4137 girls (median age 17.1 [interquartile range (IQR): 16.3-18.0]) were enrolled and followed annually until completion of secondary school (median 2.5 years [IQR: 2.4-2.7]); 4106 (99.3%) contributed to the ITT analysis. No differences in the primary composite outcome between intervention and control groups were seen (MC: 18.2%, CCT: 22.1%, combined: 22.1%, control: 19.6%; adjusted risk ratio [aRR]: 0.97, 95% confidence interval 0.76-1.24; 1.14, 0.90-1.45; and 1.13, 0.90-1.43, respectively). Incident HSV-2 occurred in 8.6%, 13.3%, 14.8%, and 12% of the MC, CCT, combined and control groups, respectively (MC: RR: 0.67, 0.47-0.95, p = 0.027; aRR: 0.71, 0.50-1.01, p = 0.057; CCT: aRR: 1.02, 0.73-1.41, p = 0.92; combined aRR: 1.16, 0.85-2.58, p = 0.36). Incident HIV was low (MC: 1.2%, CCT: 1.5%, combined: 1.0%, and control: 1.4%; aRR: 0.88, 0.38-2.05, p = 0.77, aRR: 1.16, 0.51-2.62, p = 0.72, aRR: 0.80, 0.33-1.94, p = 0.62, respectively). No intervention decreased school dropout (MC: 11.2%, CCT: 12.4%, combined: 10.9%, control: 10.5%; aRR: 1.16, 0.86-1.57; 1.23, 0.91-1.65; and 1.06, 0.78-1.44, respectively). No related serious adverse events were seen.InterpretationMCs, CCTs, or both, did not protect schoolgirls against a composite of deleterious harms. MCs appear protective against HSV-2. Studies of longer follow-up duration with objective measures of health impact are needed in this population.FundingDepartment of Health and Social Care, the Foreign, Commonwealth & Development Office, the Medical Research Council and Wellcome.

Project description:New HIV infections among sub-Saharan Africa's adolescent girls and young women (AGYW, ages 15-24) greatly exceed those of their male peers. In addition, AGYW tend to acquire HIV at a much earlier age. Understanding the factors associated with HIV infection in AGYW could inform effective prevention and treatment interventions for these populations and their male sexual partners.This qualitative study, conducted October-November 2016, was a follow on to a quantitative survey that sought to characterize male sexual partners and sexual behaviors of sexually active HIV positive AGYW in Zimbabwe. The qualitative study explored sexual behavior experiences and characteristics of male-female partnerships among the same participants. We conducted in-depth interviews with purposively sampled AGYW (16-24 years). Audio recorded qualitative data were transcribed, translated into English, and thematically coded using NVivo.28 AGYW (n = 14 urban, n = 14 rural) took part in the in-depth interviews. 50% were 16-19 years old. Discussions with 10/11 (91%) AGYW who were reportedly infected through sex suggested that they had acquired HIV from their husbands or romantic partners. Accounts also suggested that the age difference between respondents and their male sexual partners was ?5 years. Overall, respondents described two types of male partners: those older (''sugar daddies'', men ?35 years old) and younger (<35 years). Respondents felt unable to suggest condom use to both older and younger partners. Evident in respondents' accounts was a general low HIV risk perception, particularly with younger men, which was largely due to poor HIV knowledge. Discussions suggested that an AGYW's relationship with either male partner was characterized by some form of violence.Discussions highlighted the nature and characteristics of relationships between AGYW and their male sexual partners. Findings could inform interventions to engender risk perception among AGYW, promote female-controlled HIV prevention efforts and, foster risk-reduction among men.

Project description:BackgroundUnintended pregnancy has dire consequences on the health and socioeconomic wellbeing of adolescent girls and young women (AGYW) (aged 15-24 years). While most studies tend to focus on lack of access to contraceptive information and services, and poverty as the main contributing factor to early-unintended pregnancies, the influence of sexual violence has received limited attention. Understanding the link between sexual violence and unintended pregnancy is critical towards developing a multifaceted intervention to reduce unintended pregnancies among AGYW in South Africa, a country with high teenage pregnancy rate. Thus, we estimated the magnitude of unintended pregnancy among AGYW and also examined the effect of sexual violence on unintended pregnancy.MethodsOur study adopted a cross-sectional design, and data were obtained from AGYW in a South African university between June and November 2018. A final sample of 451 girls aged 17-24 years, selected using stratified sampling, were included in the analysis. We used adjusted and unadjusted logistic regression analysis to examine the effect of sexual violence on unintended pregnancy.ResultsThe analysis shows that 41.9% of all respondents had experienced an unintended pregnancy, and 26.3% of those unintended pregnancies ended in abortions. Unintended pregnancy was higher among survivors of sexual violence (54.4%) compared to those who never experienced sexual abuse (34.3%). In the multivariable analysis, sexual violence was consistently and robustly associated with increased odds of having an unintended pregnancy (AOR:1.70; 95% CI: 1.08-2.68).ConclusionOur study found a huge magnitude of unintended pregnancy among AGYW. Sexual violence is an important predictor of unintended pregnancy in this age cohort. Thus, addressing unintended pregnancies among AGYW in South Africa requires interventions that not only increase access to contraceptive information and services but also reduce sexual violence and cater for survivors.

Project description:BackgroundAdolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances.MethodsSingle site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout.DiscussionIf proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.Trial registrationClinicalTrials.gov NCT03051789 , 15th February 2017.

Project description:BackgroundEarly adolescence is a critical window for intervention when it is possible to lay a foundation for a safe transition to adulthood, before negative outcomes occur. The Adolescent Girls Initiative-Kenya randomized trial tested the effects of combinations of interventions for young adolescent girls in two sites - the Kibera informal settlement in Nairobi and rural Wajir County in the Northeastern region.MethodsThe interventions included community dialogues on the role and value of girls (violence prevention), a conditional cash transfer (education), weekly group meetings for girls with health and life skills training (health), and training and incentives for financial literacy and savings activities (wealth creation). Participants were randomized to one of four study arms: 1) violence prevention only, 2) violence prevention and education, 3) violence prevention, education and health or 4) violence prevention, education, health and wealth creation. An intent-to-treat (ITT) analysis was conducted using longitudinal data to estimate the impact of each combination of interventions and various sensitivity analyses conducted addressing potential attrition bias and multiple hypothesis testing concerns.ResultsIn Kibera, the education conditional cash transfer had small effects on grade attainment but larger impacts on completion of primary school and the transition to secondary school in the most comprehensive arm; the health intervention improved sexual and reproductive health knowledge and condom self-efficacy; and the wealth intervention improved financial literacy and savings behavior. In Wajir, the education conditional cash transfer increased school enrollment and grade attainment, and the wealth intervention improved savings behavior.ConclusionsThe results indicate that when trying to improve a range of outcomes related to adolescent wellbeing for young girls, a multisectoral intervention with components addressing household economic constraints is a promising approach.Trial registrationTrial Registry: ISRCTN, ISRCTN77455458 . Registered 24/12/2015 - Retrospectively registered.

Project description:Adolescent girls and young women (AGYW) aged 15 to 24 years face disproportionately high risks of acquiring HIV and other sexually transmitted infections (STIs). A sexual health risk stratification tool can support the development and implementation of tailored HIV and STI prevention services for sub-groups of at-risk AGYW. Data were collected among sexually active AGYW aged 15 to 24 years in Tanzania between April 2015 and March 2017. Exploratory and confirmatory factor analyses were conducted to construct and assess the latent structure of a ten-item scale for rapid assessment of sexual health risks. Items with high factor loadings and minimal cross loadings were retained in the final scale. Scale performance was appraised against condomless sex (defined as unprotected vaginal or anal intercourse) reported by AGYW for construct validity. A three-factor structure of vulnerability to HIV among AGYW was supported with subscales for socioeconomic vulnerability; lack of adult support; and sexual behavioral risks. The chi-square goodness-of-fit test, root mean square error of approximation, comparative fit index, and Tucker-Lewis index indicated a strong goodness-of-fit of the three-factor scale. Cronbach alphas (0.55 for socioeconomic vulnerability, 0.55 for lack of support, and 0.48 for sexual risk) indicated sub-optimal internal consistency for all sub-scales. The factor-item and factor-factor correlations identified in these analyses were consistent with the conceptual framework of vulnerability of HIV infection in AGYW, suggesting good construct validity. The scale also demonstrated a statistically significant association with condomless sex and could be potentially used for sexual health risk stratification (OR = 1.17, 95% CI: 1.12, 1.23). The sexual health and HIV risk stratification scale demonstrated potential in identifying sexually active AGYW at high risk for HIV and other STIs. Ultimately, all AGYW in Tanzania are not at equal risk for HIV and this scale may support directing resources towards those at highest risk of HIV.

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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

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