Development of an HIV Self-testing Intervention
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ClinicalTrials.gov Identifier: NCT02999243 |
Recruitment Status :
Terminated
(IRB expired, PI no longer at institution.)
First Posted : December 21, 2016
Last Update Posted : January 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV Serosorting | Behavioral: HIV self-testing Behavioral: Harm reduction education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | August 15, 2017 |
Actual Primary Completion Date : | May 21, 2018 |
Actual Study Completion Date : | May 21, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: HIV self-testing
HIV self-testing kits plus harm reduction education materials will be offered to the intervention group.
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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.
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Behavioral: Harm reduction education
Both arms will receive harm reduction education |
- Change in participants' HIV testing uptake [ Time Frame: Baseline and 9-month ]Change in proportion of participants being tested for HIV
- Change in partners' HIV testing uptake [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 9-month ]Change in proportion of participants who report symptoms of STIs
- Incident HIV infection [ Time Frame: Baseline and 9-month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
-

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
China, Jiangsu | |
Jiangsu Provincial Center for Disease Control and Prevention | |
Nanjing, Jiangsu, China, 210009 |
Principal Investigator: | Chongyi Wei, DrPH | University of California, San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02999243 |
Other Study ID Numbers: |
1R34MH109359 ( U.S. NIH Grant/Contract ) |
First Posted: | December 21, 2016 Key Record Dates |
Last Update Posted: | January 22, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |