ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 38 for:    ("sex behavior" OR "sexual behavior" OR "sex risk behavior") AND (teen OR adolescent) AND HIV risk | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03583541
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
Columbia University
Johns Hopkins University
Rakai Health Sciences Program
Reach the Youth Uganda
Information provided by (Responsible Party):
Fred Ssewamala, Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Control arm_Bolstered Care Treatment arm_HIVRR+S Treatment arm_HIVRR+S+FLM Behavioral: HIV Risk Reduction Behavioral: Financial Literacy Behavioral: Mentorship Behavioral: Matched savings individual development account Not Applicable

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) to be used on short- and/or long-term consumption and skills development as per participants' own discretion (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 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Kyaterekera Project: A Combination Intervention Addressing Sexual Risk-Taking Behaviors Among Vulnerable Women in Uganda
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Control arm: Bolstered treatment
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
This is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention.

Experimental: Treatment arm: HIVRR+S
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).
Behavioral: HIV 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.

Behavioral: Matched 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.

Experimental: Treatment arm: HIVRR+S+FLM
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.
Behavioral: HIV 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.

Behavioral: Financial 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.

Behavioral: Mentorship
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 (such as 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.

Behavioral: Matched 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.




Primary Outcome Measures :
  1. STI incidence [ Time Frame: baseline, 12 and 24 months post-intervention initiation ]
    Change in STI incidence as measured by laboratory assays


Secondary Outcome Measures :
  1. Sexual risk taking_unprotected sexual acts [ Time Frame: baseline, 12 and 24 months post-intervention initiation ]
    percentage of unprotected sexual acts by partner type

  2. Sexual risk taking_protective practices [ Time Frame: baseline, 12 and 24 months post-intervention initiation ]
    percentage of protective practices (e.g. PrEP uptake, ART adherence, condom use)

  3. STI testing and treatment [ Time Frame: 24 months post-intervention initiation ]
    rates of STI testing and treatment as measured by chart review

  4. Proportion of income from sex work, non-sex work, savings, debt [ Time Frame: baseline, 12 and 24 months post-intervention initiation ]
    Proportion of income from sex work, non-sex work, savings, debt as measured by economic indicators questionnaire

  5. Intervention cost [ Time Frame: through study completion, approximately 4 years ]
    Cost of staff time, supplies, overhead for HIVRR and for SMF as measured by admin review and project records



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be female.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583541


Contacts
Contact: Fred M Ssewamala, PhD 314-935-9362 fms1@wustl.edu
Contact: Susan Witte, PhD 212-851-2394 ssw12@columbia.edu

Locations
Uganda
International Center for Child Health and Development Field Office Not yet recruiting
Masaka, Uganda
Contact: Miriam Musaka, BA    +256793888717    miriam2mukasa@gmail.com   
Contact: Joshua Kiyingi, BA       joshkiyingi@gmail.com   
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Johns Hopkins University
Rakai Health Sciences Program
Reach the Youth Uganda
Investigators
Principal Investigator: Fred M Ssewamala, PhD Washington University School of Medicine
Principal Investigator: Susan Witte, PhD Columbia University

Responsible Party: Fred Ssewamala, William E. Gordon Distinguished Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03583541     History of Changes
Other Study ID Numbers: MH116768
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Ssewamala, Washington University School of Medicine:
Vulnerable women
Female sex workers
Combination interventions
Economic empowerment
HIV/AIDS
Sexually transmitted infections
Sub-Saharan Africa
Uganda