N/A
N=542
Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Control arm_Bolstered Care · Treatment arm_HIVRR+S+FL · Treatment arm_HIVRR+S+FL+M
Bottom Line
View on ClinicalTrials.gov: NCT03583541 ↗Enrolled (actual)
542
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With STIs — 17; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV Risk Reduction (Behavioral); Financial Literacy (Behavioral); Mentorship (Behavioral); Matched savings individual development account (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With STIs |
17; 39 | — |
| PRIMARY Number of Unprotected Sexual Acts With a Regular Partner |
5.16; 4.39 | — |
| PRIMARY Number of Unprotected Sexual Acts With a Paying Partner |
0.45; 0.62 | — |
| SECONDARY Number of Participants With HIV |
65; 117 | — |
| SECONDARY Viral Suppression |
50; 91 | — |
| SECONDARY Proportion of Income From Sex Work |
0.57; 0.58 | — |
| SECONDARY Preventive Behaviors/Condom Use With a Paying Partner |
2.12; 1.89 | — |
| SECONDARY Preventive Behaviors/Condom Use With a Regular Partner |
0.41; 0.34 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- at least 18 years old
- report having engaged in vaginal or anal intercourse in the past 90 days in exchange for money, alcohol, or other goods
- 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
- have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during Informed Consent process
- are unwilling or unable to commit to completing the study
- have previously been randomized.
Data sourced from ClinicalTrials.gov (NCT03583541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.