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

Control arm_Bolstered Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03583541
• Other study ID #: R01MH116768
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 542
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Control arm_Bolstered Care
• Treatment arm_HIVRR+S+FL
• Treatment arm_HIVRR+S+FLM

Intervention

Behavioral:
• HIV Risk Reduction
This is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention.
• Financial Literacy
This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management. Undarga adaptation for FSWs included shortening and simplifying sessions while retaining core elements; adding weekly check-ins due to safety concerns FSWs share related to intervention participation, and safety planning as needed. We will further adapt sessions in months 1-6 to assure language and illustrative examples are culturally consonant, and to infuse BE principles consistent with HIVRR. During sessions 1 & 2 we will include information on delay discounting, for example, learning to understand the tendency to prefer small immediate rewards over larger available at a later time; sessions 3 & 4 will include details on economic utility; sessions 5 will contain information on salience (e.g. understanding occasions when women may minimize triggers to unsafe sex); and session 6 will address loss aversion.
• Mentorship
Mentorship. Mentorship to bridge the transition from FL and savings to a vocational change is a critical component of this intervention. These sessions are intended to support the transition -equipped with financial literacy and savings -to vocational, educational, employment or small business development training using matched savings. The mentorship sessions are adapted from the pilot study and integrate components (e.g., referral and linkage, coaching, exchange visits to model farmers) from income-generating activities provided by our collaborating partner, RTY. All sessions include check-in and individual attention. The first 4 sessions focus on identifying options for vocational, educational, employment or business development training. The second 4 sessions include invited experts in identified areas of interest by group members for more intensive time and attention to individualized needs to make the transition.
• Matched savings individual development account
A matched savings individual development account (hereafter IDA) is a savings account held at a local bank whereby deposits made by the woman are matched by the intervention to encourage savings and investment in skills and asset development. The accounts introduce women to financial management skills, introduce them to formal financial institutions, and by matching their deposits, incentivize women to save small amounts. Each woman will receive an IDA held in her own name. Women will be allowed and indeed encouraged to contribute up to 50,000 shillings (~15 USD) per month towards their IDAs. The maximum amount of women's contribution to be matched will be an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements will be generated for women to note their accumulated savings. During the intervention, women will have direct access to both their personal savings deposited in the accounts and the match provided by the study.

Locations

Country	Name	City	State
Uganda	International Center for Child Health and Development Field Office	Masaka

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	Columbia University, Indiana University, Rakai Health Sciences Program, Reach the Youth Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

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