Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Guided by Social Cognitive and Asset theories as well as Behavioral Economics (BE)
 principles,the proposed RCT is carefully designed to test the additive contributions of
 savings-led microfinance beyond traditional HIV risk reduction (HIVRR) alone in decreasing
 biologically confirmed STIs, including HIV, improving high risk behavioral outcomes, while
 concurrently reducing income from sex work. Working within established health care- and
 outreach-based settings, we will randomly assign 990 FSWs to one of three study arms (11 town
 centers each): (1) a control arm comprising treatment as usual (TAU) for FSWs (quarterly 2-3
 hour health education sessions, HIV testing services, and STI screening), bolstered with 4
 evidence-based sessions of HIVRR provided by local providers (n=330 ); or (2) a treatment arm
 including TAU, 4 sessions of HIVRR, combined with receipt of a matched savings account
 (HIVRR+S) to be used on short-term and/or long term consumption and skills development per a
 participant's discretion/choice (n=330); or (3) a treatment arm including TAU, 4 sessions of
 HIVRR, combined with a matched savings account for short-term and/or long term consumption
 and skills development, plus 6 sessions of financial literacy with integrated BE principles
 (e.g., delay discounting, economic utility, information salience, and loss aversion), and 8
 mentoring sessions for supportive transition to options for alternative income (HIVRR+S+FLM)
 (n=330).*

 *Revision note: Following COVID-19, with approval from NIMH (on record if requested), the
 HIVRR+S+FLM treatment of the study has been combined with the HIVRR+S+FL treatment arm. The
 total sample size has been revised to 542 participants, with approval from NIMH. Moreover,
 biomarker data collection at 6 and 12 months were suspended due to COVID-19.
Female Sex Workers (FSWs) in sub-Saharan Africa (SSA) have been identified as a high-risk
 group for the spread of HIV/AIDS, with those in poor areas and "HIV hotspots" being
 especially vulnerable. Research has shown that the primary reason poor women engage in
 commercial sex work is financial instability. Given these challenges, poor women require
 support over and above HIV prevention education. We propose to test the impact of adding
 economic empowerment (EE) components to traditional HIV risk reduction (HIVRR) to reduce new
 incidence of sexually transmitted infections (STIs) and of HIV among FSWs in Rakai and Masaka
 districts in Uganda. Guided by social-cognitive and asset theories, the study provides an
 avenue for FSWs to explore alternative means of safe and sustainable income to replace sex
 work. The study is informed by a previously tested microfinance (MF) intervention for FSWs in
 Mongolia, a pilot study conducted with FSWs in Masaka and Rakai, surveillance studies by
 RHSP, and EE interventions among AIDS-affected families in Uganda. Using a cluster-design we
 will randomly assign 990 FSWs from 33 matched town centers to one of three study arms (11
 town centers in each condition): (1) A control arm comprising of treatment as usual (TAU) for
 FSWs in the study area bolstered with 4 evidence-based sessions of HIVRR provided by local
 providers (n=330); or (2) A treatment arm including TAU, 4 sessions of HIVRR, combined with
 receipt of a matched savings account (HIVRR+S+FL) to be used on short- and/or long-term
 consumption and skills development as per participants' own discretion plus 6 sessions of
 financial literacy (n=330); or (3) A treatment arm including TAU, 4 sessions of HIVRR,
 combined with a matched savings account to be used on short-term and/or long term consumption
 and skills development as per a participant's own discretion plus 6 sessions of financial
 literacy and 8 mentoring sessions for supportive transition to alternative income options
 (HIVRR+S+FLM) (n=330).* This RCT study's aims are to:

 Aim1: Examine the impact of a financial savings-led MF intervention using HIVRR+S+FL and
 HIVRR+S+FLM on HIV biological and behavioral outcomes in FSWs (Primary outcomes: women's
 cumulative incidence of biologically confirmed STIs and reported number and proportion of
 unprotected sexual acts with regular and paying partners; Secondary outcomes: women's rate of
 new HIV cases, proportion of monthly income from sex and nonsex work, reported number and
 proportion on preventive behaviors, and for HIV+ women only, viral load as a marker of ART
 adherence).

 Aim 2: Examine intervention mediation and effect modification to assess whether primary
 outcomes are mediated/moderated by participant characteristics; whether key theory-driven
 variables and Behavioral Economics measures mediate/moderate intervention outcomes.

 Aim 3: Qualitatively and quantitatively examine implementation in each study condition; Aim
 4: Assess the cost and cost-effectiveness of the HIVRR+S+FL and HIVRR+S+FLM intervention
 compared with traditional HIVRR in terms of cumulative number of STI and HIV cases averted
 over the 24-month period.

 *Revision note: Following COVID-19, with approval from NIMH (on record if requested), the
 HIVRR+S+FLM treatment of the study has been combined with the HIVRR+S+FL treatment arm. The
 total sample size has been revised to 542 participants, with approval from NIMH. Moreover,
 biomarker data collection at 6 and 12 months were suspended due to COVID-19.
Inclusion Criteria:

 1. at least 18 years old

 2. report having engaged in vaginal or anal intercourse in the past 90 days in exchange
 for money, alcohol, or other goods

 3. report at least one episode of unprotected sexual intercourse in the past 90 days with
 either a paying, casual, or regular sexual partner.

 Exclusion Criteria:

 1. have a cognitive or severe psychiatric impairment that would prevent comprehension of
 study procedures as assessed during Informed Consent process

 2. are unwilling or unable to commit to completing the study

 3. have previously been randomized.