Trial Outcomes & Findings for Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda (NCT NCT03583541)

NCT ID: NCT03583541

Last Updated: 2025-04-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 542 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2025-04-09

Participant Flow

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.

Participant milestones

Measure	Control Arm: Bolstered Treatment Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Overall Study STARTED	186	356
Overall Study COMPLETED	155	291
Overall Study NOT COMPLETED	31	65

Reasons for withdrawal

Measure	Control Arm: Bolstered Treatment Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Overall Study Lost to Follow-up	31	65

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Arm: Bolstered Treatment n=186 Participants Women in the control condition (and in the treatment arms) will receive treatment as usual (TAU) which 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 of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=356 Participants Women in this arm will receive TAU for FSW and the 4 HIVRR sessions, and two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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.	Total n=542 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 7.18 • n=5 Participants	31.4 years STANDARD_DEVIATION 7.39 • n=7 Participants	31.4 years STANDARD_DEVIATION 7.18 • n=5 Participants
Sex: Female, Male Female	186 Participants n=5 Participants	356 Participants n=7 Participants	542 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	186 Participants n=5 Participants	356 Participants n=7 Participants	542 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Uganda	186 participants n=5 Participants	356 participants n=7 Participants	542 participants n=5 Participants
Number of Participants with STIs	24 participants n=5 Participants	33 participants n=7 Participants	57 participants n=5 Participants
Number of Participants with HIV	79 participants n=5 Participants	141 participants n=7 Participants	220 participants n=5 Participants
Number of Unprotected Sexual Acts with a Regular Partner	3.96 unprotected sexual acts STANDARD_DEVIATION 8.96 • n=5 Participants	4.52 unprotected sexual acts STANDARD_DEVIATION 9.41 • n=7 Participants	4.33 unprotected sexual acts STANDARD_DEVIATION 9.26 • n=5 Participants
Number of Unprotected Sexual Acts with a Paying Partner	3.09 unprotected sexual acts STANDARD_DEVIATION 11.83 • n=5 Participants	2.41 unprotected sexual acts STANDARD_DEVIATION 8.86 • n=7 Participants	2.64 unprotected sexual acts STANDARD_DEVIATION 9.98 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Due to missing data, the number of participants analyzed reduced to 411 (35 participants missing STI data).

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=143 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=268 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Number of Participants With STIs	17 Participants	39 Participants

PRIMARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Number of Unprotected Sexual Acts With a Regular Partner	5.16 unprotected sexual acts Standard Deviation 8.25	4.39 unprotected sexual acts Standard Deviation 8.52

PRIMARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Number of Unprotected Sexual Acts With a Paying Partner	0.45 unprotected sexual acts Standard Deviation 1.23	0.62 unprotected sexual acts Standard Deviation 1.87

SECONDARY outcome

Timeframe: 24 months

Population: Only participants who tested HIV negative as 18 months follow-up assessments were retested.

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Number of Participants With HIV	65 Participants	117 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Viral suppression was only assessed from participants who tested positive for HIV at 24-months follow-up.

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=65 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=117 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Viral Suppression	50 Participants	91 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Proportion of Income From Sex Work	0.57 proportion of income Interval 0.4 to 0.8	0.58 proportion of income Interval 0.33 to 1.0

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Preventive Behaviors/Condom Use With a Paying Partner	2.12 preventive behaviors Standard Deviation 2.99	1.89 preventive behaviors Standard Deviation 2.51

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Control Arm: Bolstered Treatment n=155 Participants Women in the control condition received treatment as usual (TAU) which includes: health education, HIV testing services, STI screening and treatment in a 2-hour session, provided on a quarterly basis. TAU was bolstered with 4 sessions of an evidence-based, HIV/STI risk reduction (HIVRR) intervention	Treatment Arm: HIVRR+S+FL n=291 Participants Women in this arm received TAU and the 4 HIVRR sessions, plus two additional intervention components: 1) Financial Literacy: This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management; and 2) Matched savings individual development account.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 received an IDA held in their own name. Women were allowed to contribute up to 50,000 shillings (\~15 USD) per month towards their IDAs. The maximum amount of women's contribution was an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements were generated for women to note their accumulated savings. During the intervention, women had direct access to both their personal savings deposited in the accounts and the match provided by the study. Women's monthly transactions were tracked using financial diaries.
Preventive Behaviors/Condom Use With a Regular Partner	0.41 preventive behaviors Standard Deviation 2.15	0.34 preventive behaviors Standard Deviation 1.53

Adverse Events

Control Arm: Bolstered Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Arm: HIVRR+S+FL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fred Ssewamala

Washington University in St. Louis

Phone: 3149358521

Email: fms1@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place