Development of an HIV Self-testing Intervention

Sponsor

University of California, San Francisco (Other)

Overall Status

Terminated

CT.gov ID

NCT02999243

Collaborator

Jiangsu Provincial Center for Diseases Control and Prevention, China (Other)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Serosorting	Behavioral: HIV self-testing Behavioral: Harm reduction education	N/A

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 15, 2017

Actual Primary Completion Date :

May 21, 2018

Actual Study Completion Date :

May 21, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in participants' HIV testing uptake [Baseline and 9-month]
Change in proportion of participants being tested for HIV

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

University of California, San Francisco
Jiangsu Provincial Center for Diseases Control and Prevention, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT02999243

Other Study ID Numbers:

1R34MH109359

First Posted:

Dec 21, 2016

Last Update Posted:

Jan 22, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 22, 2020