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Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. OBJECTIVE:The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. METHODS:We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. RESULTS:Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. CONCLUSIONS:This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. TRIAL REGISTRATION:ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15314.

SUBMITTER: Subramanian S

PROVIDER: S-EPMC6797972 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial.

Subramanian Sujha S Edwards Patrick P Roberts Sarah T ST Musheke Maurice M Mbizvo Michael M

JMIR research protocols 20191003 10

<h4>Background</h4>Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability.<h4>Objective</h4>The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of ...[more]

PMID: 31584004

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Project description:BackgroundThe 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.ObjectiveThe 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.MethodsThe 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.ResultsThe 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.ConclusionsThis 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 registrationClinicaltrials.gov NCT03597243; https://clinicaltrials.gov/ct2/show/NCT03597243.International registered report identifier (irrid)DERR1-10.2196/14696.

Project description:IntroductionAdolescent girls and young women (AGYW) in Africa have high HIV incidence despite scale-up of HIV testing and HIV treatment. Placebo-controlled trials of tenofovir-based pre-exposure prophylaxi (PrEP) in diverse populations demonstrated that PrEP works with close to 100% effectiveness if taken with high, but not perfect, adherence. Divergent efficacy estimates among African AGYW led to demonstration and implementation projects to better understand motivations for HIV prevention, uptake, adherence and persistence to PrEP. To inform PrEP programmes, the design and initial findings from PrEP demonstration projects for AGYW are reviewed.DiscussionEarly lessons from PrEP implementation projects among young African women include: (1) awareness and demand creation with positive messaging about the benefits of PrEP are critical to motivate AGYW to consider this novel prevention technology and to foster awareness among peers, partners, parents and guardians to support AGYW's effective PrEP use; (2) PrEP initiation is high in projects that are integrating PrEP into youth-friendly clinics, family planning clinics and mobile clinics; (3) young African women at risk are initiating PrEP, based on behavioural characteristics, history of intimate partner violence, depression and 30% prevalence of chlamydia and/or gonorrhoea; (4) provision of youth-friendly PrEP delivery programmes that integrate reproductive health services, including contraception and the diagnosis and treatment of sexually transmitted infections, increase health impact; (5) messages that emphasize the necessity for high adherence while at potential risk of HIV exposure and support strategies that addresses AGYW's adherence challenges are essential; and, (6) a substantial proportion of AGYW do not persist with PrEP, and strategies are needed to help AGYW assess their ongoing need, motivation and challenges with persisting with PrEP.ConclusionsPrEP is feasible to implement in integrated reproductive health service delivery models to reach African AGYW. While PrEP demonstration projects indicate that women with behavioural risks and high rates of sexually transmitted diseases are initiating PrEP; effective strategies to support AGYW's adherence and persistence with PrEP are needed. Lessons learned from oral PrEP delivery, a novel first generation HIV prevention product, are relevant to longer-acting and less adherence-dependent strategies which are currently in clinical trials.

Project description:INTRODUCTION:In sub-Saharan Africa, adolescent girls and young women (AGYW) face a range of sexual and reproductive health (SRH) challenges. Clinical, behavioural and structural interventions have each reduced these risks and improved health outcomes. However, combinations of these interventions have not been compared with each other or with no intervention at all. The 'Girl Power' study is designed to systematically make these comparisons. METHODS AND ANALYSIS:Four comparable health facilities in Malawi and South Africa (n=8) were selected and assigned to one of the following models of care: (1) Standard of care: AGYW can receive family planning, HIV testing and counselling (HTC), and sexually transmitted infection (STI) syndromic management in three separate locations with three separate queues with the general population. No youth-friendly spaces, clinical modifications or trainings are offered, (2) Youth-Friendly Health Services (YFHS): AGYW are meant to receive integrated family planning, HTC and STI services in dedicated youth spaces with youth-friendly modifications and providers trained in YFHS, (3) YFHS+behavioural intervention (BI): In addition to YFHS, AGYW can attend 12 monthly theory-driven, facilitator-led, interactive sessions on health, finance and relationships, (4) YFHS+BI+conditional cash transfer (CCT): in addition to YFHS and BI, AGYW receive up to 12 CCTs conditional on monthly BI session attendance.At each clinic, 250 AGYW 15-24 years old (n=2000 total) will be consented, enrolled and followed for 1 year. Each participant will complete a behavioural survey at enrolment, 6 months and 12 months . All clinical, behavioural and CCT services will be captured. Outcomes of interest include uptake of each package element and reduction in HIV risk behaviours. A qualitative substudy will be conducted. ETHICS/DISSEMINATION:This study has received ethical approval from the University of North Carolina Institutional Review Board, the University of Cape Town Human Research Ethics Committee and Malawi's National Health Sciences Research Committee. Study plans, processes and findings will be disseminated to stakeholders, in peer-reviewed journals and at conferences.

Project description:IntroductionRecent advances in the HIV care continuum have shown that an individual diagnosed with HIV should be initiated on antiretroviral therapy as soon as possible regardless of the CD4 count levels and retained in HIV care services. Studies have reported large losses in the HIV continuum of care, before and after the era of universal test and treat. Several systematic reviews have reported on the strategies for improving linkage to and retention in HIV treatment and care. The purpose of this overview of systematic reviews is to identify HIV care interventions or service delivery models (SDMs) and synthesise evidence on the effects of these to link adolescent girls and young women (AGYW) and adolescent boys and young men (ABYM) to care and retain them in care. We also aim to highlight gaps in the evidence on interventions and SDMs to improve linkage and retention in HIV care of AGYW and ABYM.Methods and analysisAn electronic search of four online databases: PubMed, Cochrane Database of Systematic Reviews, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science will be performed to identify systematic reviews on the effects of linkage to and retention in HIV care interventions or SDMs for AGYW aged 15-24 years and ABYM aged 15-35 years. Our findings on the effects of interventions and SDMs will be interpreted considering the intervention and or SDMs' effectiveness by the time period, setting and population of interest. Two or more authors will independently screen articles for inclusion using a priori criteria.Ethics and disseminationEthics approval is not required for this study as only published secondary data will be used. Our findings will be disseminated through peer-reviewed publication, conference abstracts and through presentations to stakeholders and other community fora. The findings from this overview of systematic reviews will inform mixed-methods operations research on HIV intervention programming and delivery of HIV care services for AGYW and ABYM in South Africa.Prospero registration numberCRD42020177933.

Project description:BACKGROUND:Young women in sub-Saharan Africa remain at the epicentre of the HIV epidemic, with surveillance data indicating persistent high levels of HIV incidence. In South Africa, adolescent girls and young women (AGYW) account for a quarter of all new HIV infections. Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) is a strategy introduced by the United States President's Emergency Plan for AIDS Relief (PEPFAR) aimed at reducing HIV incidence among AGYW in 10 countries in sub-Saharan Africa by 25% in the programme's first year, and by 40% in the second year. This study will assess the change in HIV incidence and reduction in risk associated behaviours that can be attributed to the DREAMS initiative in South Africa, using a population-based cross-sectional survey. METHODS:Data will be collected from a household-based representative sample of AGYW (between the ages 12-24 years) in four high prevalence districts (more than 10% of the population have HIV in these districts) in South Africa in which DREAMS has been implemented. A stratified cluster-based sampling approach will be used to select eligible participants for a cross-sectional survey with 18,500, to be conducted over 2017/2018. A questionnaire will be administered containing questions on sexual risk behaviour, selected academic and developmental milestones, prevalence of gender based violence, whilst examining exposure to DREAMS programmes. Biological samples, including two micro-containers of blood and self-collected vulvovaginal swab samples, are collected in each survey to test for HIV infection, HIV incidence, sexually transmitted infections (STIs) and pregnancy. This study will measure trends in population level HIV incidence using the Limiting antigen (LAg) Avidity Enzyme Immuno-Assay (EIA) and monitor changes in HIV incidence. DISCUSSION:Ending the HIV/AIDS pandemic by 2030 requires the continual monitoring and evaluation of prevention programmes, with the aim of optimising efforts and ensuring the achievement of epidemic control. This study will determine the impact DREAMS interventions have had on HIV incidence among AGYW in a 'real world, non-trial setting'.

Project description:BackgroundSouth Africa has the world's largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5-7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW.MethodsThis is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15-19-year-old Black South African AGYW and their FC-dyads in Cape Town's informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics.DiscussionPrimary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority.Trial registrationClinicalTrials.gov Number NCT04758390 , accepted 02/16/2021.

Project description:BackgroundDespite increased prevention efforts, HIV remains the leading cause of death among adolescent girls and young women in South Africa. Although research indicates important determinants of HIV acquisition at the individual and interpersonal levels, structural-level stigma and discrimination continue to be critical barriers to reaching and retaining this key population for HIV prevention and sexual and reproductive health services. Innovative and multilevel interventions are needed that can address the intersectional structural and gender issues that young women face, including stigma, alcohol and drug use, gender-based violence, and other risk factors when seeking health services. Oral pre-exposure prophylaxis (PrEP) taken daily has been found to be an effective biomedical HIV prevention tool. Testing a comprehensive gender-focused biobehavioral HIV prevention intervention that is inclusive of social ecological determinants, such as stigma and discrimination reduction in clinics, is critical for reducing HIV among adolescent girls and young women.MethodsThis project involves both a Community Collaborative Board and a Youth Advisory Board in helping to adapt the Young Women's Health CoOp intervention and the Health Policy Project (HPP) Stigma and Discrimination (S&D) reduction training curriculum to the setting and population. This study uses a two-by-two factorial design with stratified randomization of 12 clinics, each with distinct catchment areas. The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health. Adolescent girls and young women will be assessed with behavioral and biological measures at baseline, 3-, 6- and 9-month follow-up. The S&D reduction training is provided for all staff in the clinics randomized to this condition. Clinic staff will be surveyed at baseline, 4- and 8-month follow-up. We will recruit 900 AGYW from communities in the 12 clinic catchment areas.DiscussionThe study findings, if efficacious across the outcomes, will be incorporated into the gender-focused HIV prevention intervention toolkit and disseminated to inform multilevel prevention approaches.Trial registrationClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered).

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.

Dataset Information

Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial.

Publications

Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial.

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