NCT02999243

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

December 14, 2016

Last Update Submit

January 21, 2020

Conditions

HIV Serosorting

Outcome Measures

Primary Outcomes (1)

  • Change in participants' HIV testing uptake

    Change in proportion of participants being tested for HIV

    Baseline and 9-month

Secondary Outcomes (4)

  • Change in partners' HIV testing uptake

    Baseline and 9-month

  • Questionnaire to assess change in awareness of partner's HIV status

    Baseline and 9-month

  • Questionnaire to assess change in self-reported sexually transmitted infection (STI) symptoms

    Baseline and 9-month

  • Incident HIV infection

    Baseline and 9-month

Study Arms (2)

HIV self-testing

EXPERIMENTAL

HIV self-testing kits plus harm reduction education materials will be offered to the intervention group.

Behavioral: HIV self-testingBehavioral: Harm reduction education

Education

PLACEBO COMPARATOR

Harm reduction educational materials will be offered to the control group.

Behavioral: Harm reduction education

Interventions

HIV self-testingBEHAVIORAL

The intervention group will be offered HIV self-testing kits for testing HIV status

HIV self-testing
Harm reduction educationBEHAVIORAL

Both arms will receive harm reduction education

EducationHIV self-testing

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (13)

  • Li D, Li S, Liu Y, Gao Y, Yu M, Yang X, Li Q, Jiang S, Zhou Z, Zhang Z, Yan L, Jiang G, Xiao D, Pan SW, Luo F, Ruan Y, Shao Y. HIV incidence among men who have sex with men in Beijing: a prospective cohort study. BMJ Open. 2012 Nov 19;2(6):e001829. doi: 10.1136/bmjopen-2012-001829. Print 2012.

    PMID: 23166133BACKGROUND

  • Wang QQ, Chen XS, Yin YP, Liang GJ, Zhang RL, Jiang N, Huan XP, Yang B, Liu Q, Zhou YJ, Wang BX. HIV prevalence, incidence and risk behaviours among men who have sex with men in Yangzhou and Guangzhou, China: a cohort study. J Int AIDS Soc. 2014 Aug 6;17(1):18849. doi: 10.7448/IAS.17.1.18849. eCollection 2014.

    PMID: 25103308BACKGROUND

  • Xu JJ, Zhang M, Brown K, Reilly K, Wang H, Hu Q, Ding H, Chu Z, Bice T, Shang H. Syphilis and HIV seroconversion among a 12-month prospective cohort of men who have sex with men in Shenyang, China. Sex Transm Dis. 2010 Jul;37(7):432-9. doi: 10.1097/OLQ.0b013e3181d13eed.

    PMID: 20375928BACKGROUND

  • Yan H, Yang H, Zhao J, Wei C, Li J, Huan X, Zhang M, Raymond HF, McFarland W. Long-chain peer referral of men who have sex with men: a novel approach to establish and maintain a cohort to measure HIV incidence, Nanjing, China. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):177-84. doi: 10.1097/QAI.0b013e318239c947.

    PMID: 21992923BACKGROUND

  • Chow EP, Iu KI, Fu X, Wilson DP, Zhang L. HIV and sexually transmissible infections among money boys in China: a data synthesis and meta-analysis. PLoS One. 2012;7(11):e48025. doi: 10.1371/journal.pone.0048025. Epub 2012 Nov 29.

    PMID: 23209551BACKGROUND

  • Snowden JM, Wei C, McFarland W, Raymond HF. Prevalence, correlates and trends in seroadaptive behaviours among men who have sex with men from serial cross-sectional surveillance in San Francisco, 2004-2011. Sex Transm Infect. 2014 Sep;90(6):498-504. doi: 10.1136/sextrans-2013-051368. Epub 2014 Mar 31.

    PMID: 24687128BACKGROUND

  • Eaton LA, Kalichman SC, O'Connell DA, Karchner WD. A strategy for selecting sexual partners believed to pose little/no risks for HIV: serosorting and its implications for HIV transmission. AIDS Care. 2009 Oct;21(10):1279-88. doi: 10.1080/09540120902803208.

    PMID: 20024704BACKGROUND

  • Xia Q, Molitor F, Osmond DH, Tholandi M, Pollack LM, Ruiz JD, Catania JA. Knowledge of sexual partner's HIV serostatus and serosorting practices in a California population-based sample of men who have sex with men. AIDS. 2006 Oct 24;20(16):2081-9. doi: 10.1097/01.aids.0000247566.57762.b2.

    PMID: 17053354BACKGROUND

  • Mitchell JW, Horvath KJ. Factors associated with regular HIV testing among a sample of US MSM with HIV-negative main partners. J Acquir Immune Defic Syndr. 2013 Dec 1;64(4):417-23. doi: 10.1097/QAI.0b013e3182a6c8d9.

    PMID: 23933766BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Prevalence and awareness of HIV infection among men who have sex with men --- 21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Sep 24;59(37):1201-7.

    PMID: 20864920BACKGROUND

  • He N, Detels R. The HIV epidemic in China: history, response, and challenge. Cell Res. 2005 Nov-Dec;15(11-12):825-32. doi: 10.1038/sj.cr.7290354.

    PMID: 16354555BACKGROUND

  • Gari S, Doig-Acuna C, Smail T, Malungo JR, Martin-Hilber A, Merten S. Access to HIV/AIDS care: a systematic review of socio-cultural determinants in low and high income countries. BMC Health Serv Res. 2013 May 28;13:198. doi: 10.1186/1472-6963-13-198.

    PMID: 23714167BACKGROUND

  • Wei C, Yan L, Li J, Su X, Lippman S, Yan H. Which user errors matter during HIV self-testing? A qualitative participant observation study of men who have sex with men (MSM) in China. BMC Public Health. 2018 Sep 10;18(1):1108. doi: 10.1186/s12889-018-6007-3.

    PMID: 30200905DERIVED

MeSH Terms

Conditions

HIV Serosorting

Condition Hierarchy (Ancestors)

Risk Reduction BehaviorBehaviorSexual Behavior

Study Officials

  • Chongyi Wei, DrPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 21, 2016

Study Start

August 15, 2017

Primary Completion

May 21, 2018

Study Completion

May 21, 2018

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)