Control arm_Bolstered Care, Treatment arm_HIVRR+S+FL, Treatment arm_HIVRR+S+FL+M
Conditions
Keywords
Vulnerable women, Female sex workers, Combination interventions, Economic empowerment, HIV/AIDS, Sexually transmitted infections, Sub-Saharan Africa, Uganda
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.
Interventions
BEHAVIORALHIV Risk Reduction
This is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention.
BEHAVIORALFinancial Literacy
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.
BEHAVIORALMentorship
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.
BEHAVIORALMatched savings individual development account
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.
Sponsors
Columbia University
Indiana University
Rakai Health Sciences Program
Reach the Youth Uganda
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With STIs | 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 | 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 | 24 months | Number of unprotected sexual acts (e.g. vaginal and anal sexual acts) with a paying partner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preventive Behaviors/Condom Use With a Paying Partner | 24 months | Preventive behaviors was assessed by number of times a participant used condoms with a paying partner during sexual acts. |
| Number of Participants With HIV | 24 months | Number of participants testing positive for HIV, assessed using biomarker data. |
| Preventive Behaviors/Condom Use With a Regular Partner | 24 months | Preventive behaviors was assessed by number of times a participant used condoms with a regular partner during sexual acts. |
| Viral Suppression | 24 months | Viral Suppression for women living with HIV was assessed using detectable vs undetectable viral load. |
| Proportion of Income From Sex Work | 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. |
Countries
Uganda
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm: Bolstered Treatment 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 | 186 |
| Treatment Arm: HIVRR+S+FL 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. | 356 |
| Total | 542 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 31 | 65 |
Baseline characteristics
| Characteristic | Total | Control Arm: Bolstered Treatment | Treatment Arm: HIVRR+S+FL |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 7.18 | 31.2 years STANDARD_DEVIATION 7.18 | 31.4 years STANDARD_DEVIATION 7.39 |
| Number of Participants with HIV | 220 participants | 79 participants | 141 participants |
| Number of Participants with STIs | 57 participants | 24 participants | 33 participants |
| Number of Unprotected Sexual Acts with a Paying Partner | 2.64 unprotected sexual acts STANDARD_DEVIATION 9.98 | 3.09 unprotected sexual acts STANDARD_DEVIATION 11.83 | 2.41 unprotected sexual acts STANDARD_DEVIATION 8.86 |
| Number of Unprotected Sexual Acts with a Regular Partner | 4.33 unprotected sexual acts STANDARD_DEVIATION 9.26 | 3.96 unprotected sexual acts STANDARD_DEVIATION 8.96 | 4.52 unprotected sexual acts STANDARD_DEVIATION 9.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 542 Participants | 186 Participants | 356 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 542 participants | 186 participants | 356 participants |
| Sex: Female, Male Female | 542 Participants | 186 Participants | 356 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 0 / 356 |
| other Total, other adverse events | 0 / 186 | 0 / 356 |
| serious Total, serious adverse events | 0 / 186 | 0 / 356 |
Outcome results
Primary
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
Time frame: 24 months
Population: Due to missing data, the number of participants analyzed reduced to 411 (35 participants missing STI data).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm: Bolstered Treatment | Number of Participants With STIs | 17 Participants |
| Treatment Arm: HIVRR+S+FL | Number of Participants With STIs | 39 Participants |
Primary
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm: Bolstered Treatment | Number of Unprotected Sexual Acts With a Paying Partner | 0.45 unprotected sexual acts | Standard Deviation 1.23 |
| Treatment Arm: HIVRR+S+FL | Number of Unprotected Sexual Acts With a Paying Partner | 0.62 unprotected sexual acts | Standard Deviation 1.87 |
Primary
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm: Bolstered Treatment | Number of Unprotected Sexual Acts With a Regular Partner | 5.16 unprotected sexual acts | Standard Deviation 8.25 |
| Treatment Arm: HIVRR+S+FL | Number of Unprotected Sexual Acts With a Regular Partner | 4.39 unprotected sexual acts | Standard Deviation 8.52 |
Secondary
Number of Participants With HIV
Number of participants testing positive for HIV, assessed using biomarker data.
Time frame: 24 months
Population: Only participants who tested HIV negative as 18 months follow-up assessments were retested.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm: Bolstered Treatment | Number of Participants With HIV | 65 Participants |
| Treatment Arm: HIVRR+S+FL | Number of Participants With HIV | 117 Participants |
Secondary
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm: Bolstered Treatment | Preventive Behaviors/Condom Use With a Paying Partner | 2.12 preventive behaviors | Standard Deviation 2.99 |
| Treatment Arm: HIVRR+S+FL | Preventive Behaviors/Condom Use With a Paying Partner | 1.89 preventive behaviors | Standard Deviation 2.51 |
Secondary
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm: Bolstered Treatment | Preventive Behaviors/Condom Use With a Regular Partner | 0.41 preventive behaviors | Standard Deviation 2.15 |
| Treatment Arm: HIVRR+S+FL | Preventive Behaviors/Condom Use With a Regular Partner | 0.34 preventive behaviors | Standard Deviation 1.53 |
Secondary
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.
Time frame: 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm: Bolstered Treatment | Proportion of Income From Sex Work | 0.57 proportion of income |
| Treatment Arm: HIVRR+S+FL | Proportion of Income From Sex Work | 0.58 proportion of income |
Secondary
Viral Suppression
Viral Suppression for women living with HIV was assessed using detectable vs undetectable viral load.
Time frame: 24 months
Population: Viral suppression was only assessed from participants who tested positive for HIV at 24-months follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm: Bolstered Treatment | Viral Suppression | 50 Participants |
| Treatment Arm: HIVRR+S+FL | Viral Suppression | 91 Participants |