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

NCT03583541 | Completed Results DMC

• 1 other identifier: R01MH116768
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  24 months

Secondary Outcomes (5)

• Number of Participants With HIV

  24 months

• Viral Suppression

  24 months

• Proportion of Income From Sex Work

  24 months

• Preventive Behaviors/Condom Use With a Paying Partner

  24 months

• Preventive Behaviors/Condom Use With a Regular Partner

  24 months

Study Arms (3)

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

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

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.

Behavioral: HIV Risk Reduction; Behavioral: Financial Literacy; Behavioral: Mentorship; Behavioral: Matched savings individual development account

Interventions

HIV Risk Reduction BEHAVIORAL

This is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention.

Control arm: Bolstered treatment; Treatment arm: HIVRR+S+FL; Treatment arm: HIVRR+S+FLM

Financial Literacy BEHAVIORAL

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.

Treatment arm: HIVRR+S+FL; Treatment arm: HIVRR+S+FLM

Mentorship BEHAVIORAL

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.

Treatment arm: HIVRR+S+FLM

Matched savings individual development account BEHAVIORAL

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.

Treatment arm: HIVRR+S+FL; Treatment arm: HIVRR+S+FLM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Columbia University: collaborator
• Indiana University: collaborator
• Rakai Health Sciences Program: collaborator
• Reach the Youth Uganda: collaborator

Study Sites (1)

International Center for Child Health and Development Field Office

Masaka, Uganda

Location

Related Publications (7)

• 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.

  PMID: 41211615 DERIVED

• Nabayinda 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.

  PMID: 38581814 DERIVED

• Sensoy 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.

  PMID: 36634037 DERIVED

• Jennings 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.

  PMID: 35510547 DERIVED

• 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.

  PMID: 35128367 DERIVED

• 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.

  PMID: 33881949 DERIVED

• 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.

  PMID: 31419968 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study implementation (including recruitment, data collection and intervention delivery) was greatly impacted by COVID-19 and associated mitigating risks. Following COVID-19, with approval from NIMH (on record if requested), the HIVRR+S+FLM treatment arm of the study was combined with the HIVRR+S+FL treatment arm. The total sample size was revised to 542 participants, with approval from NIMH. Moreover, biomarker data collection at 6 and 12 months were suspended due to COVID-19.

Results Point of Contact

• Title: Fred Ssewamala
• Organization: Washington University in St. Louis

fms1@wustl.edu

3149358521

Study Officials

• Fred M Ssewamala, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Susan Witte, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William E. Gordon Distinguished Professor

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 11, 2018
• Study Start: August 1, 2019
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

UG (1)