Control arm_Bolstered CareNCT03583541
Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
A study testing HIV Risk Reduction, Financial Literacy and Mentorship in people with Control arm_Bolstered Care and Treatment arm_HIVRR+S+FL, run by Washington University School of Medicine at 1 site in Uganda.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Control arm_Bolstered Care, Treatment arm_HIVRR+S+FL, Treatment arm_HIVRR+S+FL+M
- What is being tested?
- HIV Risk Reduction, Financial Literacy and Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUganda
- Study dates
- 1 Aug 2019to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
International Center for Child Health and Development Field Office
Masaka
About this study
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.
Read the 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.
- Being tested
- HIV Risk Reduction, Financial Literacy, Mentorship, Matched savings individual development account
- Keywords
- Vulnerable women, Female sex workers, Combination interventions, Economic empowerment, HIV/AIDS, Sexually transmitted infections, Sub-Saharan Africa, Uganda
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Risk ReductionBehavioural
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 LiteracyBehavioural
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.
MentorshipBehavioural
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 accountBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm: Bolstered treatment | Experimental | 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 Receives: Behavioral: HIV Risk Reduction |
| Treatment arm: HIVRR+S+FL | Experimental | 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 Receives: Behavioral: HIV Risk Reduction; Behavioral: Financial Literacy; Behavioral: Matched savings individual development account |
| Treatment arm: HIVRR+S+FLM | Experimental | 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 arm 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. Receives: Behavioral: HIV Risk Reduction; Behavioral: Financial Literacy; Behavioral: Mentorship; Behavioral: Matched savings individual development account |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With STIs
Number of participants testing positive for any of the three STI including Gonorrhea, Trichomonas or Chlamydia, as assessed using biomarkers
Measured: 24 months
Number of Unprotected Sexual Acts With a Regular Partner
Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a regular partner
Measured: 24 months
Number of Unprotected Sexual Acts With a Paying Partner
Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a paying partner
Measured: 24 months
Secondary outcomes (5)
Number of Participants With HIV
Number of participants testing positive for HIV, assessed using biomarker data.
Measured: 24 months
Viral Suppression
Viral Suppression for women living with HIV was assessed using detectable vs undetectable viral load.
Measured: 24 months
Proportion of Income From Sex Work
Participants reported their average total income and proportion of income from sex work. Proportion of income from sex work was calculated as average monthly total income as the denominator and income from sex work as the numerator.
Measured: 24 months
Preventive Behaviors/Condom Use With a Paying Partner
Preventive behaviors was assessed by number of times a participant used condoms with a paying partner during sexual acts.
Measured: 24 months
Preventive Behaviors/Condom Use With a Regular Partner
Preventive behaviors was assessed by number of times a participant used condoms with a regular partner during sexual acts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Aug 2019
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Control arm_Bolstered CareStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Indiana University, Rakai Health Sciences Program, Reach the Youth Uganda
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
- Investigators
- Fred M Ssewamala, PhD, Principal investigator, Washington University School of MedicineSusan Witte, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583541
- Sponsor's protocol ID
- R01MH116768
- Status last verified
- Mar 2025
- First submitted
- 31 May 2018
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PIs and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Brown School of Social Work and Columbia University School of Social Work Office of Sponsored Projects' data sharing agreements.
Publications
Witte SS, Ssewamala FM, Kiyingi J, Bellamy SL, Yang LS, Nabunya P, Bahar OS, Mayo-Wilson LJ, Tozan Y, Mwebembezi A, Kagaayi J. A cluster-randomized controlled trial of a combination HIV risk reduction and economic empowerment intervention for women engaged in sex work in Uganda. J Int AIDS Soc. 2025 Nov;28(11):e70057. doi: 10.1002/jia2.70057.
PubMed 41211615Nabayinda J, Witte SS, Kizito S, Nanteza F, Nsubuga E, Sensoy Bahar O, Nabunya P, Ssewamala FM. The impact of an economic empowerment intervention on intimate partner violence among women engaged in sex work in southern Uganda: A cluster randomized control trial. Soc Sci Med. 2024 May;348:116846. doi: 10.1016/j.socscimed.2024.116846. Epub 2024 Apr 3.
PubMed 38581814Sensoy Bahar O, Nabunya P, Nabayinda J, Witte S, Kiyingi J, Nsubuga E, Schriger S, Nattabi J, Mayo-Wilson LJ, Nakigudde J, Tozan Y, Ssewamala FM. "I decided in my heart I have to complete the sessions": A qualitative study on the acceptability of an evidence-based HIV risk reduction intervention among women engaged in sex work in Uganda. PLoS One. 2023 Jan 12;18(1):e0280138. doi: 10.1371/journal.pone.0280138. eCollection 2023.
PubMed 36634037Jennings Mayo-Wilson L, Yen BJ, Nabunya P, Bahar OS, Wright BN, Kiyingi J, Filippone PL, Mwebembezi A, Kagaayi J, Tozan Y, Nabayinda J, Witte SS, Ssewamala FM. Economic Abuse and Care-seeking Practices for HIV and Financial Support Services in Women Employed by Sex Work: A Cross-Sectional Baseline Assessment of a Clinical Trial Cohort in Uganda. J Interpers Violence. 2023 Jan;38(1-2):NP1920-NP1949. doi: 10.1177/08862605221093680. Epub 2022 May 5.
PubMed 35510547Witte 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.
PubMed 35128367Nabunya 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.
PubMed 33881949Ssewamala 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.
PubMed 31419968
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
- ClinicalTrials.gov ID
- NCT03583541
- Acronym / sponsor ID
- R01MH116768
- Keywords
- Vulnerable women, Female sex workers, Combination interventions, Economic empowerment, HIV/AIDS, Sexually transmitted infections, Sub-Saharan Africa, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Columbia University, Indiana University, Rakai Health Sciences Program, Reach the Youth Uganda
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm: Bolstered treatment | Experimental | Behavioral: HIV Risk ReductionWomen 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 | Experimental | Behavioral: HIV Risk Reduction, Behavioral: Financial Literacy, Behavioral: Matched savings individual development accountWomen 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 | Experimental | Behavioral: HIV Risk Reduction, Behavioral: Financial Literacy, Behavioral: Mentorship, Behavioral: Matched savings individual development accountWomen 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 arm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Risk ReductionThis is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention. | Behavioural | Control arm: Bolstered treatment, Treatment arm: HIVRR+S+FL, Treatment arm: HIVRR+S+FLM |
| Financial LiteracyThis 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. | Behavioural | Treatment arm: HIVRR+S+FL, Treatment arm: HIVRR+S+FLM |
| MentorshipMentorship. 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. | Behavioural | Treatment arm: HIVRR+S+FLM |
| Matched savings individual development accountA 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. | Behavioural | Treatment arm: HIVRR+S+FL, Treatment arm: HIVRR+S+FLM |
Primary outcome
Number of Participants With STIs
Time frame: 24 months
Number of participants testing positive for any of the three STI including Gonorrhea, Trichomonas or Chlamydia, as assessed using biomarkers
Number of Unprotected Sexual Acts With a Regular Partner
Time frame: 24 months
Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a regular partner
Number of Unprotected Sexual Acts With a Paying Partner
Time frame: 24 months
Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a paying partner
5 secondary outcomes
Number of Participants With HIV
Time frame: 24 months
Viral Suppression
Time frame: 24 months
Proportion of Income From Sex Work
Time frame: 24 months
Preventive Behaviors/Condom Use With a Paying Partner
Time frame: 24 months
Preventive Behaviors/Condom Use With a Regular Partner
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41211615Witte SS, Ssewamala FM, Kiyingi J, Bellamy SL, Yang LS, Nabunya P, Bahar OS, Mayo-Wilson LJ, Tozan Y, Mwebembezi A, Kagaayi J. A cluster-randomized controlled trial of a combination HIV risk reduction and economic empowerment intervention for women engaged in sex work in Uganda. J Int AIDS Soc. 2025 Nov;28(11):e70057. doi: 10.1002/jia2.70057.
- Derived from this study: PubMed 38581814Nabayinda J, Witte SS, Kizito S, Nanteza F, Nsubuga E, Sensoy Bahar O, Nabunya P, Ssewamala FM. The impact of an economic empowerment intervention on intimate partner violence among women engaged in sex work in southern Uganda: A cluster randomized control trial. Soc Sci Med. 2024 May;348:116846. doi: 10.1016/j.socscimed.2024.116846. Epub 2024 Apr 3.
- Derived from this study: PubMed 36634037Sensoy Bahar O, Nabunya P, Nabayinda J, Witte S, Kiyingi J, Nsubuga E, Schriger S, Nattabi J, Mayo-Wilson LJ, Nakigudde J, Tozan Y, Ssewamala FM. "I decided in my heart I have to complete the sessions": A qualitative study on the acceptability of an evidence-based HIV risk reduction intervention among women engaged in sex work in Uganda. PLoS One. 2023 Jan 12;18(1):e0280138. doi: 10.1371/journal.pone.0280138. eCollection 2023.
- Derived from this study: PubMed 35510547Jennings Mayo-Wilson L, Yen BJ, Nabunya P, Bahar OS, Wright BN, Kiyingi J, Filippone PL, Mwebembezi A, Kagaayi J, Tozan Y, Nabayinda J, Witte SS, Ssewamala FM. Economic Abuse and Care-seeking Practices for HIV and Financial Support Services in Women Employed by Sex Work: A Cross-Sectional Baseline Assessment of a Clinical Trial Cohort in Uganda. J Interpers Violence. 2023 Jan;38(1-2):NP1920-NP1949. doi: 10.1177/08862605221093680. Epub 2022 May 5.
- Derived from this study: PubMed 35128367Witte 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.
- Derived from this study: PubMed 33881949Nabunya 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.
- Derived from this study: PubMed 31419968Ssewamala 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.
- Individual participant dataSharing planned: Yes. Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PIs and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Brown School of Social Work and Columbia University School of Social Work Office of Sponsored Projects' data sharing agreements.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred M Ssewamala, PhD principal investigator
Washington University School of Medicine
Susan Witte, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Risk Reduction, Financial Literacy and Mentorship in people with Control arm_Bolstered Care and Treatment arm_HIVRR+S+FL, run by Washington University School of Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With STIs (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583541, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.