Development of an HIV Self-testing Intervention

January 21, 2020 updated by: University of California, San Francisco

Development of an HIV Self-testing Intervention to Reduce HIV Risks Among MSM: Taking the Guess Out of Seroguessing

This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST) facilitates sexual harm reduction and reduces HIV transmission among HIV-negative MSM in China.The intervention group will be offered HIVST kits plus harm reduction education, and followed 9 month, while the control group will receive harm reduction educational material only.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The HIV epidemic in China is now concentrated among men who have sex with men (MSM), who account for a third of new HIV infections. Despite strengthened prevention efforts and increased availability of HIV testing in the country, testing rates are low and condomless sex is common among Chinese MSM. Globally, condomless sex among MSM, particularly with primary partners, is also ubiquitous. To reduce HIV transmission risks in the context of condomless sex, MSM communities have adopted a range of sexual harm reduction strategies (i.e., seroadaptive behaviors). Essential to the effectiveness of these strategies is accurate knowledge of HIV status within the partnership. This necessitates frequent HIV testing and mutual HIV status disclosure. However, significant proportions of MSM have never tested or not recently tested and are unaware of their own and their partner's HIV status, especially in settings where sexual minorities are stigmatized. Among Chinese MSM, their ability to successfully use these harm reduction strategies is severely limited by low levels of HIV testing and disclosure efficacy. As a result, many Chinese MSM make unreliable assumptions about their own and their partners' serostatus (i.e., seroguessing), resulting in risky condomless sex. As many of these men do not access facility-based testing, new and emerging HIV testing options must be expanded to help these men make informed decisions about sexual risk and harm reduction. HIV self-testing (HIVST) offers a promising prevention strategy to reach more untested Chinese MSM, increase testing frequency, and serve as a valuable prevention tool to assist harm reduction. The investigators propose to determine the feasibility and preliminary efficacy of an HIVST intervention in facilitating sexual harm reduction and reducing HIV transmission among MSM in Nanjing, China. The investigators will: 1) conduct participant observation (N = 20) and cognitive interviews (N=10) to determine what information and support is needed for MSM to use HIVST safely and practice sexual harm reduction responsibly; and 2) recruit and enroll 400 high-risk HIV-negative MSM into a RCT where the intervention group will be offered HIVST kits plus harm reduction education and followed over a 9-month period to determine whether the intervention increases uptake and frequency of testing in partnership, improves disclosure and awareness of partners' HIV status, and therefore facilitates sexual harm reduction and reduces HIV transmission. Expanding HIV testing among key populations is a priority for HIV prevention worldwide. Innovative strategies are needed to encourage MSM to seek HIV testing while taking into consideration existing paradigms of community-originated and driven harm reduction strategies. As HIVST is being introduced to different settings and becoming more accessible, findings from this proposed study will provide vital information on current patterns of seroadaptation and HIVST use; identify what is needed to promote HIVST's proper use for harm reduction and linkage to HIV/STI care, and whether HIVST can improve the accuracy of harm reduction strategies.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age 18 years or older;
  • born male;
  • currently residing in Nanjing and planning to stay as a resident during the study period;
  • speaks either Mandarin or the local dialect;
  • confirmed HIV negative through HIV rapid testing;
  • have had condomless anal sex with a man in the past six months

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV self-testing
HIV self-testing kits plus harm reduction education materials will be offered to the intervention group.
Behavioral: HIV self-testing
The intervention group will be offered HIV self-testing kits for testing HIV status
Behavioral: Harm reduction education
Both arms will receive harm reduction education
Placebo Comparator: Education
Harm reduction educational materials will be offered to the control group.
Behavioral: Harm reduction education
Both arms will receive harm reduction education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participants' HIV testing uptake
Time Frame: Baseline and 9-month
Change in proportion of participants being tested for HIV
Baseline and 9-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in partners' HIV testing uptake
Time Frame: Baseline and 9-month
Change in proportion of participants' partners who tested for HIV
Baseline and 9-month
Questionnaire to assess change in awareness of partner's HIV status
Time Frame: Baseline and 9-month
Change in proportion of participants' who report that they are aware of their partners' HIV status
Baseline and 9-month
Questionnaire to assess change in self-reported sexually transmitted infection (STI) symptoms
Time Frame: Baseline and 9-month
Change in proportion of participants who report symptoms of STIs
Baseline and 9-month
Incident HIV infection
Time Frame: Baseline and 9-month
Baseline and 9-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Jiangsu Provincial Center for Diseases Control and Prevention, China

Investigators

  • Principal Investigator: Chongyi Wei, DrPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

May 21, 2018

Study Completion (Actual)

May 21, 2018

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1R34MH109359 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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