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Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial.

ABSTRACT: BACKGROUND:Among women at high risk for HIV and other sexually transmitted diseases (STIs), gender and economic issues limit the impact of behavioral prevention strategies. Women in Kazakhstan with dual risks of sex trading and drug use face elevated risk for HIV and STIs and may benefit from an economic empowerment intervention which combines HIV-risk reduction (HIVRR) education with financial skills-building and asset-building to promote reduced reliance on sex trading for income. METHODS/DESIGN:The study employs a two-arm, cluster-randomized controlled trial (c-RCT) design. We will use cluster randomization to assign 350 women in approximately 50 cohorts to a traditional four-session HIV-risk-reduction intervention combined with a six-session financial literacy intervention, enrollment in a 24-session vocational training program and receipt of matched savings (HIVRR+MF); or to the four-session HIV-risk-reduction intervention alone (HIVRR). Repeated behavioral and biological assessments will be conducted at baseline, then at 6, 9, and 15 months post randomization/session 1. DISCUSSION:This study responds to an identified need in the academic literature for rigorous testing of structural interventions, including combination microfinance and HIV-prevention interventions. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02406482 . Registered on 30 March 2015.

SUBMITTER: McCrimmon T

PROVIDER: S-EPMC5859522 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial.

McCrimmon Tara T Witte Susan S Mergenova Gaukhar G Terlikbayeva Assel A Primbetova Sholpan S Kuskulov Azamat A Bellamy Scarlett L SL El-Bassel Nabila N

Trials 20180320 1

<h4>Background</h4>Among women at high risk for HIV and other sexually transmitted diseases (STIs), gender and economic issues limit the impact of behavioral prevention strategies. Women in Kazakhstan with dual risks of sex trading and drug use face elevated risk for HIV and STIs and may benefit from an economic empowerment intervention which combines HIV-risk reduction (HIVRR) education with financial skills-building and asset-building to promote reduced reliance on sex trading for income.<h4>M ...[more]

PMID: 29558982

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Project description:IntroductionFemale sex workers (FSW) who use drugs are a key population at risk of HIV in Kazakhstan, and face multiple structural barriers to HIV prevention. More research is needed on the role of structural interventions such as microfinance (MF) in reducing HIV risk. This paper describes the results of a cluster-randomized controlled trial to test the efficacy of a combination HIVRR + MF intervention in reducing biologically confirmed STIs and HIV risk behaviours.MethodsThis study took place from May 2015 to October 2018 in two cities in Kazakhstan. We screened 763 participants for eligibility and enrolled 354 FSW who use drugs. Participants were randomized in cohorts to receive either a four-session HIVRR intervention, or that same intervention plus 30 additional sessions of financial literacy training, vocational training and asset-building through a matched-savings programme. Repeated behavioural and biological assessments were conducted at baseline, 3-, 6- and 12-months post-intervention. Biological and behavioural primary outcomes included HIV/STI incidence, sexual risk behaviours and drug use risk behaviours, evaluated over the 12-month period.ResultsOver the 12-month follow-up period, few differences in study outcomes were noted between arms. There was only one newly-detected HIV case, and study arms did not significantly differ on any STI incidence. At post-intervention assessments compared to baseline, both HIVRR and HIVRR + MF participants significantly reduced sexual and drug use risk behaviours, and showed improvements in financial outcomes, condom use attitudes and self-efficacy, social support, and access to medical care. In addition, HIVRR + MF participants showed a 72% greater reduction in the number of unprotected sex acts with paying partners at the six-month assessment (IRR = IRR = 0.28, 95% CI = 0.08, 0.92), and a 10% greater reduction in the proportion of income from sex work at the three-month assessment (b = -0.10, 95% CI = -0.17, -0.02) than HIVRR participants did. HIVRR + MF participants also showed significantly improved performance on financial self-efficacy compared to HIVRR over the 12-month follow-up period.ConclusionsCompared to a combination HIVRR + MF intervention, a robust HIVRR intervention alone may be sufficient to reduce sexual and drug risk behaviours among FSW who use drugs. There may be structural limitations to the promise of microfinance for HIV risk reduction among this population.

Project description:IntroductionOver one-third of human immunodeficiency virus (HIV)-infected pregnant women are clinically depressed, increasing the risk of mother-to-child transmission (MTCT) of HIV, as well as negative birth and child development outcomes. This study will evaluate the efficacy and cost-effectiveness of an evidence-based stepped care treatment model for perinatal depression (maternal depression treatment in HIV [M-DEPTH]) to improve adherence to prevention of MTCT care among HIV+ women in Uganda.MethodsEight antenatal care (ANC) clinics in Uganda will be randomized to implement either M-DEPTH (n=4) or usual care (n=4) for perinatal depression among 400 pregnant women (n=50 per clinic) between June 2019 and August 2022. At each site, women who screen positive for potential depression will be enrolled and followed for 18 months post-delivery, assessed in 6-month intervals: baseline, within 1 month of child delivery or pregnancy termination, and months 6, 12, and 18 following delivery. Primary outcomes include adherence to the prevention of mother-to-child transmission (PMTCT) care continuum-including maternal antiretroviral therapy and infant antiretrovial prophylaxis, and maternal virologic suppression; while secondary outcomes will include infant HIV status, post-natal maternal and child health outcomes, and depression treatment uptake and response. Repeated-measures multivariable regression analyses will be conducted to compare outcomes between M-DEPTH and usual care, using 2-tailed tests and an alpha cut-off of P <.05. Using a micro-costing approach, the research team will relate costs to outcomes, examining the incremental cost-effectiveness ration (ICER) of M-DEPTH relative to care as usual.DiscussionThis cluster randomized controlled trial will be one of the first to compare the effects of an evidence-based depression care model versus usual care on adherence to each step of the PMTCT care continuum. If determined to be efficacious and cost-effective, this study will provide a model for integrating depression care into ANC clinics and promoting adherence to PMTCT.Trial registrationNIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov).

Project description:BackgroundAmong 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.ObjectiveThe 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.MethodsWe 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.ResultsInterim 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.ConclusionsThis 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 registrationClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953.International registered report identifier (irrid)PRR1-10.2196/15314.

Project description:BackgroundOral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women.MethodsThe Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16-24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16-24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants' perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention's fidelity and cost.DiscussionEvidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings.Trial registrationClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

Project description:BackgroundHIV testing is an essential gateway to HIV prevention and treatment thus controlling the HIV epidemic. More innovative interventions are needed to increase HIV testing among men who have sex with men (MSM) since their testing rate is still low. We proposed an online HIV test results exchange mechanism whereby the one without a certified online HIV report will be asked to test HIV for exchanging HIV report with others. The exchange mechanism is developed as an extension to the existing online HIV testing service system. Through the extended system, MSM can obtain certified online HIV reports and exchange their reports with friends via WeChat. This study aims to assess effectiveness of the exchange mechanism to increase the HIV testing rate among MSM.MethodsThis study will use a cluster randomized controlled trial (RCT) design. Participants are recruited based on the unit of individual social network, the sender and the receivers of the HIV report. An individual social network is composed of one sender (ego) and one or more receivers (alters). In this study, MSM in an HIV testing clinic are recruited as potential egos and forwarded online reports to their WeChat friends voluntarily. Friends are invited to participate by report links and become alters. Ego and alters serve as a cluster and are randomized to the group using the certified online HIV report with exchange mechanism (intervention group) or without exchange mechanism (control group). Alters are the intervention targeting participants. The primary outcome is HIV testing rate. Other outcomes are sexual transmitted infections, sexual behaviors, HIV testing norms, stigma, risk perception and HIV report delivery. The outcomes will be assessed at baseline and follow-up questionnaires. Analysis will be according to intention to treat approach and using mixed-effect models with networks and individuals as random effects.DiscussionThis is the first study to evaluate the effectiveness of an HIV test result exchange mechanism to increase the HIV testing among MSM. This assessment of the intervention will also provide scientific evidence on other potential effects. Findings from this study will yield insights for sustainability driven by communities' intrinsic motivation. Trail registration: ClinicalTrials.gov NCT03984136. Registered 12 June 2019.

Project description:IntroductionIn Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF).Methods and analysisWe will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved.Ethics and disseminationThe Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication.Trial registration numberNCT04417127.

Dataset Information

Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial.

Publications

Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial.

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