Kyaterekera Project: a Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda

Not Applicable

Completed

• Conditions: Control Arm_Bolstered Care; Treatment Arm_HIVRR+S+FL; Treatment Arm_HIVRR+S+FLM
• Interventions: Behavioral: HIV Risk Reduction; Behavioral: Financial Literacy; Behavioral: Mentorship; Behavioral: Matched savings individual development account

• Registration Number: NCT03583541
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-11
• Study Start: 2019-08-01
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 542

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm: Bolstered treatment	HIV Risk Reduction	Women in the control condition (and in the treatment arms) will receive treatment as usual (TAU) for FSW in the study area. Provided by RHSP, TAU includes: health education, HIV testing services, STI screening and treatment in a session that lasts about 2 hours, provided on a quarterly basis. This will be bolstered with 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention
Treatment arm: HIVRR+S+FL	HIV Risk Reduction	Women in this arm will receive TAU for FSW and the 4 HIVRR sessions (described above) and a single session following HIVRR specifically describing bank account opening, the matching process, and how to interact with banks. In this session our partnering banks will open up matched savings accounts for women in the two treatment arms. Women in both arms will save money in their matched savings accounts over a 10-month period post HIVRR. The study team will monitor the accounts using the statements received directly from the banks holding the accounts. Participants will receive monthly bank statements indicating their own savings and the associated match (1:1 match rate). They will also receive 6 financial literacy (FL) sessions provided twice a week for 3 weeks
Treatment arm: HIVRR+S+FL	Financial Literacy	Women in this arm will receive TAU for FSW and the 4 HIVRR sessions (described above) and a single session following HIVRR specifically describing bank account opening, the matching process, and how to interact with banks. In this session our partnering banks will open up matched savings accounts for women in the two treatment arms. Women in both arms will save money in their matched savings accounts over a 10-month period post HIVRR. The study team will monitor the accounts using the statements received directly from the banks holding the accounts. Participants will receive monthly bank statements indicating their own savings and the associated match (1:1 match rate). They will also receive 6 financial literacy (FL) sessions provided twice a week for 3 weeks
Treatment arm: HIVRR+S+FLM	Matched savings individual development account	Women in this arm will receive TAU and the 4 HIVRR sessions (as above). Next, they will receive the savings session (described above) and 6 financial literacy (FL) sessions provided twice a week for 3 weeks, followed by 8 mentorship (M) sessions supporting transition to vocational, educational training, employment or business development, and receipt of a matched savings account to be used on short-term and/or long term consumption and skills development per participants own discretion/choice. \*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 532 participants, with approval from NIMH.
Treatment arm: HIVRR+S+FL	Matched savings individual development account	Women in this arm will receive TAU for FSW and the 4 HIVRR sessions (described above) and a single session following HIVRR specifically describing bank account opening, the matching process, and how to interact with banks. In this session our partnering banks will open up matched savings accounts for women in the two treatment arms. Women in both arms will save money in their matched savings accounts over a 10-month period post HIVRR. The study team will monitor the accounts using the statements received directly from the banks holding the accounts. Participants will receive monthly bank statements indicating their own savings and the associated match (1:1 match rate). They will also receive 6 financial literacy (FL) sessions provided twice a week for 3 weeks
Treatment arm: HIVRR+S+FLM	Mentorship	Women in this arm will receive TAU and the 4 HIVRR sessions (as above). Next, they will receive the savings session (described above) and 6 financial literacy (FL) sessions provided twice a week for 3 weeks, followed by 8 mentorship (M) sessions supporting transition to vocational, educational training, employment or business development, and receipt of a matched savings account to be used on short-term and/or long term consumption and skills development per participants own discretion/choice. \*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 532 participants, with approval from NIMH.
Treatment arm: HIVRR+S+FLM	HIV Risk Reduction	Women in this arm will receive TAU and the 4 HIVRR sessions (as above). Next, they will receive the savings session (described above) and 6 financial literacy (FL) sessions provided twice a week for 3 weeks, followed by 8 mentorship (M) sessions supporting transition to vocational, educational training, employment or business development, and receipt of a matched savings account to be used on short-term and/or long term consumption and skills development per participants own discretion/choice. \*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 532 participants, with approval from NIMH.
Treatment arm: HIVRR+S+FLM	Financial Literacy	Women in this arm will receive TAU and the 4 HIVRR sessions (as above). Next, they will receive the savings session (described above) and 6 financial literacy (FL) sessions provided twice a week for 3 weeks, followed by 8 mentorship (M) sessions supporting transition to vocational, educational training, employment or business development, and receipt of a matched savings account to be used on short-term and/or long term consumption and skills development per participants own discretion/choice. \*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 532 participants, with approval from NIMH.

Primary Outcome Measures

Name	Time	Method
STI incidence	baseline, 6, and 18 months post-intervention initiation	Change in STI incidence as measured by laboratory assays

Secondary Outcome Measures

Name	Time	Method
STI testing and treatment	24 months post-intervention initiation	rates of STI testing and treatment as measured by chart review
Sexual risk taking_protective practices	baseline, 6, 12, 18 and 24 months post-intervention initiation	percentage of protective practices (e.g. PrEP uptake, ART adherence, condom use)
Proportion of income from sex work, non-sex work, savings, debt	baseline, 6, 12, 18 and 24 months post-intervention initiation	Proportion of income from sex work, non-sex work, savings, debt as measured by economic indicators questionnaire
Sexual risk taking_unprotected sexual acts	baseline, 6, 12, 18 and 24 months post-intervention initiation	percentage of unprotected sexual acts by partner type
Intervention cost	through study completion, approximately 4 years	Cost of staff time, supplies, overhead for HIVRR and for SMF as measured by admin review and project records
HIV incidence	baseline, 6, and 18 months post-intervention initiation	Change in STI incidence as measured by laboratory assays

Trial Locations

Locations (1)

International Center for Child Health and Development Field Office; 🇺🇬 Masaka, Uganda