- STUDY PURPOSE AND RATIONALE. This study is a 2-arm randomized control clinical trial (RCT), Project Ascension, that will evaluate the efficacy of a combined 4-session HIV risk reduction and microfinance intervention (including 6 sessions of financial literacy skills; referral to a 36 session vocational training; and concurrent weekly matched savings from the research team) (HIVRR+MF) to reduce new HIV/STI infections and sexual and drug risk among women who inject drugs and trade sex in Temirtau and Pavlodar, Kazakhstan. The primary outcomes are to decrease new STIs, including HIV and HCV, proportion of unprotected sexual acts and proportion of income from sex work. Secondary outcomes include examining mediating and moderating factors, the examine women's experience of the intervention and cost effectiveness of the addition of MF over HIVRR alone on primary outcomes.
To evaluate the impact of the HIVRR+MF intervention we will use two sources of data: (1) individual level biological testing data for syphilis, gonorrhea, trichomonas, HIV and HCV collected from 520 participants, randomly assigned to either the treatment arm or control arm at baseline, 6-months post-intervention, and 12 months post-intervention; and (2) self-reported data collected from participants at baseline, 3 months-, 6 months-, and 12 months post-intervention. The same outcomes and variables will be collected at each time point.
We are also currently seeking approval for this study from the IRB at the Kazakh School of Public Health.
- STUDY DESIGN AND STATISTICAL PROCEDURES.
This RCT will be conducted with 520 FSW-PWID recruited from 2 NGOs, one each in Temirtau and Pavlodar, Kazakhstan. Collaborating NGOs are You are Not Alone, in Pavlodar and the Association of People Living with HIV in Temirtau. They provide the full spectrum of services for people affected by STIs and HIV, including FSW-PWID in each city. Women will be randomly assigned to either a (1) HIVRR plus Microfinance (HIVRR+MF) or (2) HIVRR alone control condition. We will compare two active conditions offering the HIV risk reduction intervention (HIVRR) to both intervention arms. This design will allow us to examine how the addition of the MF to HIVRR might lead to superior outcomes compared to receiving HIVRR alone. HIVRR intervention and the financial literacy will be delivered by research staff and vocational training will be delivered by field site staff. In month 6, recruitment will begin. We will enroll an average of 22 women per cohort per site (44 total every 2.5 months) and complete enrollment by month 35. Self-reported data on behavioral outcomes will be collected via audio computer-assisted self-interview (ACASI) and assessed at baseline, 3, 6, and 12 months post-intervention. We will implement the same survey at each time point. Primary outcomes will be measured via biological assay for Neisseria gonorrhea, Trichomoniasis, Syphilis, Chlamydia and Mycoplasma, as well as for HIV and HCV. Biological outcomes are assessed at baseline, 6 and 12 months post-intervention. Follow up assessments will start in month 15 and the final 12 month follow up will be completed in month 51. For Aim 4, we will conduct a qualitative study on women's experience with each of the HIVRR+MF components, and the unique impact of study conditions on structural factors associated with risk among FSW-PWID. For Aim 5, we will collect cost data related to each intervention component every 6 months from months 6-50. Data analyses will commence in year 5 followed by dissemination of findings.
Qualitative Study. To help open the "black box" of the delivery of HIVRR+ MF, the investigators will conduct semi structured in-depth interviews at 3 points in time during implementation of the HIVRR intervention. Following the HIVRR and financial literacy components (4 weeks post-baseline), investigators will randomly select 2 participants from each arm per cohort (total of N=48 women from 12 cohorts) to complete their first of 3 interviews. The next two interviews will be conducted at the end of the MF intervention and again at the 12 month follow up for each participant. Questions will focus on participants' perception of the intervention, their experience receiving the intervention components (including reactions or interactions with family, friends, colleagues related to their participation), their experience receiving the sessions, factors promoting the use of the session information and skills and barriers impeding participation. Importantly, questions will also focus on perceptions of how the intervention influenced participant safety, including any policy involvement, stigma or discrimination, drug use before and during the intervention, and savings and the potential access to matched savings. All interviews will be audio taped, transcribed and translated to English.
