NCT03583541

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

Completed NA Results posted Last updated 9 April 2025

What this trial tests

NA trial testing HIV Risk Reduction in Control arm_Bolstered Care in 542 participants. Completed in 23 August 2023.

Timeline

1 August 2019

Primary endpoint
23 August 2023

23 August 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	542
Start date	1 August 2019
Primary completion	23 August 2023
Estimated completion	23 August 2023
Sites	1 location across Uganda

Drugs / interventions tested

• HIV Risk Reduction
• Financial Literacy
• Mentorship
• Matched savings individual development account

Conditions studied

• Control arm_Bolstered Care — all drugs for Control arm_Bolstered Care →
• Treatment arm_HIVRR+S+FL — all drugs for Treatment arm_HIVRR+S+FL →
• Treatment arm_HIVRR+S+FL+M — all drugs for Treatment arm_HIVRR+S+FL+M →

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Control arm_Bolstered Care or Treatment arm_HIVRR+S+FL. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With STIs Primary · 24 months

Number of participants testing positive for any of the three STI including Gonorrhea, Trichomonas or Chlamydia, as assessed using biomarkers

Group	Value	95% CI
Control Arm: Bolstered Treatment	17
Treatment Arm: HIVRR+S+FL	39

Number of Unprotected Sexual Acts With a Regular Partner Primary · 24 months

Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a regular partner

Group	Value	95% CI
Control Arm: Bolstered Treatment	5.16	± 8.25
Treatment Arm: HIVRR+S+FL	4.39	± 8.52

Number of Unprotected Sexual Acts With a Paying Partner Primary · 24 months

Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a paying partner

Group	Value	95% CI
Control Arm: Bolstered Treatment	0.45	± 1.23
Treatment Arm: HIVRR+S+FL	0.62	± 1.87

Number of Participants With HIV Secondary · 24 months

Number of participants testing positive for HIV, assessed using biomarker data.

Group	Value	95% CI
Control Arm: Bolstered Treatment	65
Treatment Arm: HIVRR+S+FL	117

Viral Suppression Secondary · 24 months

Viral Suppression for women living with HIV was assessed using detectable vs undetectable viral load.

Group	Value	95% CI
Control Arm: Bolstered Treatment	50
Treatment Arm: HIVRR+S+FL	91

Proportion of Income From Sex Work Secondary · 24 months

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.

Group	Value	95% CI
Control Arm: Bolstered Treatment	0.57	0.40 – 0.80
Treatment Arm: HIVRR+S+FL	0.58	0.33 – 1

Preventive Behaviors/Condom Use With a Paying Partner Secondary · 24 months

Preventive behaviors was assessed by number of times a participant used condoms with a paying partner during sexual acts.

Group	Value	95% CI
Control Arm: Bolstered Treatment	2.12	± 2.99
Treatment Arm: HIVRR+S+FL	1.89	± 2.51

Preventive Behaviors/Condom Use With a Regular Partner Secondary · 24 months

Preventive behaviors was assessed by number of times a participant used condoms with a regular partner during sexual acts.

Group	Value	95% CI
Control Arm: Bolstered Treatment	0.41	± 2.15
Treatment Arm: HIVRR+S+FL	0.34	± 1.53

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PrEP acceptability and initiation among women engaged in sex work in Uganda: Implications for HIV prevention.
   Witte SS, Filippone P, Ssewamala FM, Nabunya P, et al · · 2022 · cited 45× · PMID 35128367 · DOI 10.1016/j.eclinm.2022.101278
2. A combination intervention addressing sexual risk-taking behaviors among vulnerable women in Uganda: study protocol for a cluster randomized clinical trial.
   Ssewamala FM, Sensoy Bahar O, Tozan Y, Nabunya P, et al · · 2019 · cited 39× · PMID 31419968 · DOI 10.1186/s12905-019-0807-1
3. Working with economically vulnerable women engaged in sex work: Collaborating with community stakeholders in Southern Uganda.
   Nabunya P, Kiyingi J, Witte SS, Sensoy Bahar O, et al · · 2022 · cited 13× · PMID 33881949 · DOI 10.1080/17441692.2021.1916054
4. 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.
   Jennings Mayo-Wilson L, Yen BJ, Nabunya P, Bahar OS, et al · · 2023 · cited 8× · PMID 35510547 · DOI 10.1177/08862605221093680
5. "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.
   Sensoy Bahar O, Nabunya P, Nabayinda J, Witte S, et al · · 2023 · cited 4× · PMID 36634037 · DOI 10.1371/journal.pone.0280138
6. 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.
   Nabayinda J, Witte SS, Kizito S, Nanteza F, et al · · 2024 · cited 3× · PMID 38581814 · DOI 10.1016/j.socscimed.2024.116846
7. "I expected little, although I learned a lot": perceived benefits of participating in HIV risk reduction sessions among women engaged in sex work in Uganda.
   Sensoy Bahar O, Nabunya P, Nabayinda J, Witte SS, et al · · 2022 · cited 3× · PMID 35562821 · DOI 10.1186/s12905-022-01759-1
8. Examining Cash Expenditures and Associated HIV-Related Behaviors Using Financial Diaries in Women Employed by Sex Work in Rural Uganda: Findings from the Kyaterekera Study.
   Jennings Mayo-Wilson L, Peterson SK, Kiyingi J, Nabunya P, et al · · 2023 · cited 1× · PMID 37174132 · DOI 10.3390/ijerph20095612