HIV Self-Testing to Empower Prevention Choices in Sex Workers

NCT03426670 | Completed DMC

• 1 other identifier: ST/189/2017
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV self-testing; Pre-exposure prophylaxis; Sex workers

Outcome Measures

Primary Outcomes (1)

• PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels

  Comparison of adherence outcomes by randomization arm

  12 months

Secondary Outcomes (4)

• High-risk sexual behaviors as measured by frequency of unprotected sex and sexually transmitted infections

  12 months

• Proportion of sex workers using self-test kits

  12 months

• Diagnostic accuracy of HIVST in oral PrEP users

  12 months

• Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires

  12 months

Study Arms (2)

OraQuick HIV Self-Test

ACTIVE COMPARATOR

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.

Device: OraQuick HIV Self-Test

In-clinic testing

NO INTERVENTION

All study participants will receive quarterly in-clinic HIV testing as standard-of-care.

Interventions

OraQuick HIV Self-Test DEVICE

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.

OraQuick HIV Self-Test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A physical or mental condition that prohibits informed consent and/or participation in study procedures

Sponsors & Collaborators

• Makerere University: lead
• University of Washington: collaborator
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Infectious Diseases Institute,Makerere University College of Health Sciences

Kampala, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrew Mujugira, MBChB, PhD

  Center Head

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 8, 2018
• Study Start: May 21, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)