HIV Self-Testing to Empower Prevention Choices in Sex Workers
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
OraQuick HIV Self-Test
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring HIV self-testing, Pre-exposure prophylaxis, Sex workers
Eligibility Criteria
Inclusion Criteria:
- Exchanged sex for goods or money at least once in the prior month
- Able and willing to provide written informed consent
- HIV-uninfected based on negative HIV rapid tests according to the national Uganda algorithm
- Adequate renal function (normal creatinine levels; calculated creatinine clearance ≥ 60ml/min)
- Not infected with Hepatitis B virus (negative HBsAg test)
- Not enrolled in HIV prevention trial currently or within the past year
- Not currently using PrEP
- Willing to remain in the study for the next 12 months
- Own a mobile phone for personal use
- Have regular access to electricity for charging a mobile phone
Exclusion Criteria:
- A physical or mental condition that prohibits informed consent and/or participation in study procedures
Sites / Locations
- Infectious Diseases Institute,Makerere University College of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
OraQuick HIV Self-Test
In-clinic testing
Arm Description
Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. HIV Self-testing will be performed during the months between scheduled quarterly visits.
All study participants will receive quarterly in-clinic HIV testing as standard-of-care.
Outcomes
Primary Outcome Measures
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels
Comparison of adherence outcomes by randomization arm
Secondary Outcome Measures
High-risk sexual behaviors as measured by frequency of unprotected sex and sexually transmitted infections
Comparison of self-reported unprotected sex and sexually transmitted infections by randomization arm
Proportion of sex workers using self-test kits
Proportion of sex workers randomized to HIV self-testing using HIV self test kits
Diagnostic accuracy of HIVST in oral PrEP users
Proportion of false negative HIV self-test tests
Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires
Proportion who believe PrEP is effective in preventing HIV infection
Full Information
NCT ID
NCT03426670
First Posted
January 10, 2018
Last Updated
February 25, 2020
Sponsor
Makerere University
Collaborators
University of Washington, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT03426670
Brief Title
HIV Self-Testing to Empower Prevention Choices in Sex Workers
Official Title
HIV Self-Testing to Empower Prevention Choices in Sex Workers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
University of Washington, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV seroprevalence (35-37%) and account for 10% of new HIV infections. Two robust, evidence-based, self-controlled HIV prevention tools are available -- HIV self-testing (HIVST) and antiretroviral pre-exposure prophylaxis (PrEP) -- but these are not currently well utilized among sex workers. HIVST and PrEP are complementary tools that could be combined to build self-efficacy and empowerment, increase PrEP adherence and reduce sexual risk behaviors. However, research is needed to show how combination HIVST and PrEP may have a synergistic impact on uptake and use of each prevention intervention. The investigators will conduct a randomized trial among sex workers initiating PrEP in Uganda to test if HIV self-testing increases PrEP adherence among HIV-uninfected sex workers (Aim 1), changes sexual risk behavior in sex workers taking PrEP (Aim 2), and influences prevention choices among sex workers and their partners (Aim 3). The investigators will use novel technologies (real-time electronic monitoring with Wise pill technology and mobile phone surveys) to characterize patterns of PrEP adherence, and assess how use of HIVST and PrEP aligns with sexual risk behaviors. Additionally, the investigators will conduct in-depth qualitative interviews to explore the mechanisms through which combined HIVST and PrEP delivery may be synergistic and empowering. This study will be the first to jointly evaluate HIVST and PrEP in sex workers.
Detailed Description
This is a randomized clinical trial of HIV-uninfected transgender, female, and male sex workers. The overall goal is to test if HIV self-testing increases PrEP adherence (Aim 1), changes sexual risk behavior (Aim 2), and influences HIV prevention choices (Aim 3) in HIV-uninfected sex workers and their partners. For Aim 1, the investigators will recruit HIV-uninfected sex workers in Kampala, Uganda and randomize them to the intervention (monthly HIVST with quarterly clinic-based testing) or the control arm (quarterly clinic-based testing). Study participants will be trained how to use and interpret HIVST and be provided with 4 kits at enrollment and each quarterly visit: 2 kits for own use and 2 for sexual partners, with additional kits provided as needed. They will be instructed to self-test before opening a new PrEP bottle. The investigators will use Wise pill technology to evaluate patterns of PrEP use, and mobile phone interviews to assess HIVST use and confidence in PrEP effectiveness. The investigators will conduct Aim 2 within the randomized trial in Aim 1 and test whether HIVST changes sexual risk behavior. The investigators will use mobile phone interviews and semi-structured questionnaires to collect the behavioral data. In Aim 3 the investigators will use qualitative methods to assess how HIVST empowers use of HIV prevention interventions among sex workers and their partners.
Aim 1: To test if HIV self-testing versus clinic-based testing increases PrEP adherence among HIV-uninfected sex workers.
Approach: To evaluate the impact of HIVST on PrEP adherence, the investigators will randomize 110 HIV-uninfected transgender, female and male sex workers initiating PrEP in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care). PrEP medications will be dispensed quarterly. Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. In this study, participants will receive counseling on the importance of strict PrEP adherence for HIV protection.
Hypothesis: Monthly HIVST will empower HIV prevention and motivate PrEP adherence among HIV-uninfected sex workers.
Aim 2: To test the effect of HIV self-testing on sexual risk behavior in sex workers taking PrEP.
Approach: Within the randomized trial in Aim 1, the investigators will provide HIVST kits to sex workers for own use, and with partners (primary and commercial). The investigators will use monthly live phone interviews and semi-structured questionnaires to collect data on high-risk sexual behaviors (e.g. sexual frequency, unprotected sex).
Hypothesis: Use of HIVST will be associated with decreased frequency of unprotected sex and sexually transmitted infections.
Aim 3: To explore how HIV self-testing influences prevention choices among sex workers and partners.
Approach: The investigators will conduct in-depth interviews with sex workers and their primary and commercial partners to assess perceptions and experiences with HIVST, explore how HIVST influences status disclosure, behavior change and PrEP use, and to better understand how mobile technology can be leveraged to motivate repeat testing in individuals at high ongoing risk of HIV.
Hypothesis: HIVST will empower sex workers to adopt protective behaviors, facilitate partner testing, and efficiently identify individuals with undiagnosed HIV infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV self-testing, Pre-exposure prophylaxis, Sex workers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OraQuick HIV Self-Test
Arm Type
Active Comparator
Arm Description
Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. HIV Self-testing will be performed during the months between scheduled quarterly visits.
Arm Title
In-clinic testing
Arm Type
No Intervention
Arm Description
All study participants will receive quarterly in-clinic HIV testing as standard-of-care.
Intervention Type
Device
Intervention Name(s)
OraQuick HIV Self-Test
Intervention Description
OraQuick® HIV Self-Test is an in-vitro diagnostic medical device that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals.
Primary Outcome Measure Information:
Title
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels
Description
Comparison of adherence outcomes by randomization arm
Time Frame
12 months
Secondary Outcome Measure Information:
Title
High-risk sexual behaviors as measured by frequency of unprotected sex and sexually transmitted infections
Description
Comparison of self-reported unprotected sex and sexually transmitted infections by randomization arm
Time Frame
12 months
Title
Proportion of sex workers using self-test kits
Description
Proportion of sex workers randomized to HIV self-testing using HIV self test kits
Time Frame
12 months
Title
Diagnostic accuracy of HIVST in oral PrEP users
Description
Proportion of false negative HIV self-test tests
Time Frame
12 months
Title
Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires
Description
Proportion who believe PrEP is effective in preventing HIV infection
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Transgender
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Exchanged sex for goods or money at least once in the prior month
Able and willing to provide written informed consent
HIV-uninfected based on negative HIV rapid tests according to the national Uganda algorithm
Adequate renal function (normal creatinine levels; calculated creatinine clearance ≥ 60ml/min)
Not infected with Hepatitis B virus (negative HBsAg test)
Not enrolled in HIV prevention trial currently or within the past year
Not currently using PrEP
Willing to remain in the study for the next 12 months
Own a mobile phone for personal use
Have regular access to electricity for charging a mobile phone
Exclusion Criteria:
A physical or mental condition that prohibits informed consent and/or participation in study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Mujugira, MBChB, PhD
Organizational Affiliation
Center Head
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Institute,Makerere University College of Health Sciences
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
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HIV Self-Testing to Empower Prevention Choices in Sex Workers
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