Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of an HIV Self-testing Intervention

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02999243
Recruitment Status : Unknown
Verified October 2017 by Chongyi Wei, University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Jiangsu Provincial Center for Diseases Control and Prevention, China
Information provided by (Responsible Party):
Chongyi Wei, University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 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 : August 15, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in participants' HIV testing uptake [ Time Frame: Baseline and 9-month ]
    Change in proportion of participants being tested for HIV


Secondary Outcome Measures :
  1. Change in partners' HIV testing uptake [ Time Frame: Baseline and 9-month ]
    Change in proportion of participants' partners who tested for HIV

  2. 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

  3. 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

  4. Incident HIV infection [ Time Frame: Baseline and 9-month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02999243


Locations
Layout table for location information
China, Jiangsu
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
Layout table for investigator information
Principal Investigator: Chongyi Wei, DrPH University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Chongyi Wei, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02999243     History of Changes
Other Study ID Numbers: 1R34MH109359 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No