Clinical trial NCT03583541: Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Official title: Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Control arm_Bolstered Care
Treatment arm_HIVRR+S+FL
Treatment arm_HIVRR+S+FL+M
Keywords: Vulnerable women
Female sex workers
Combination interventions
Economic empowerment
HIV/AIDS
Sexually transmitted infections
Sub-Saharan Africa
Uganda
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Indiana University
name: Rakai Health Sciences Program
name: Reach the Youth Uganda
First posted: 2018-07-11
Enrollment: 542
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With STIs
timeFrame: 24 months
measure: Number of Unprotected Sexual Acts With a Regular Partner
timeFrame: 24 months
measure: Number of Unprotected Sexual Acts With a Paying Partner
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants With HIV
timeFrame: 24 months
measure: Viral Suppression
timeFrame: 24 months
measure: Proportion of Income From Sex Work
timeFrame: 24 months
measure: Preventive Behaviors/Condom Use With a Paying Partner
timeFrame: 24 months
measure: Preventive Behaviors/Condom Use With a Regular Partner
timeFrame: 24 months
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development Field Office
Study officials:
affiliation: Washington University School of Medicine
name: Fred M Ssewamala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Susan Witte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witte SS, Filippone P, Ssewamala FM, Nabunya P, Bahar OS, Mayo-Wilson LJ, Namuwonge F, Damulira C, Tozan Y, Kiyingi J, Nabayinda J, Mwebembezi A, Kagaayi J, McKay M. PrEP acceptability and initiation among women engaged in sex work in Uganda: Implications for HIV prevention. EClinicalMedicine. 2022 Jan 28;44:101278. doi: 10.1016/j.eclinm.2022.101278. eCollection 2022 Feb.
citation: Nabunya P, Kiyingi J, Witte SS, Sensoy Bahar O, Jennings Mayo-Wilson L, Tozan Y, Nabayinda J, Mwebembezi A, Tumwesige W, Mukasa B, Namirembe R, Kagaayi J, Nakigudde J, McKay MM, Ssewamala FM. Working with economically vulnerable women engaged in sex work: Collaborating with community stakeholders in Southern Uganda. Glob Public Health. 2022 Jul;17(7):1215-1231. doi: 10.1080/17441692.2021.1916054. Epub 2021 Apr 21.
citation: Ssewamala FM, Sensoy Bahar O, Tozan Y, Nabunya P, Mayo-Wilson LJ, Kiyingi J, Kagaayi J, Bellamy S, McKay MM, Witte SS. A combination intervention addressing sexual risk-taking behaviors among vulnerable women in Uganda: study protocol for a cluster randomized clinical trial. BMC Womens Health. 2019 Aug 17;19(1):111. doi: 10.1186/s12905-019-0807-1.