Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV

NCT04971967 | Completed Results

• 2 other identifiers: 19-0496R34MH119963
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals will participate in a pilot randomized controlled trial (RCT) that implements and evaluates the feasibility, acceptability, and effectiveness of crowdsourced partner services (PS) or conventional PS among Chinese men who have sex with men (MSM) living with HIV. The pilot RCT will include 120 newly identified MSM HIV cases who were born biologically male, aged 18 years old or older, newly identified as HIV positive, had oral or anal sex with a man, had at least one sexual partner in the previous 6 months and live in Guangzhou. Participants will undergo a series of computer-based interviews (baseline and 2 months after enrollment) and will be randomly assigned into two groups in 2:1 ratio (intervention: control) and receive crowdsourced PS and conventional PS, respectively.

Conditions

Contact Tracing

Keywords

Partner notification services; Crowdsourcing; MSM; HIV

Outcome Measures

Primary Outcomes (3)

• Percentage of MSM Index Cases That Respond to the Follow-up Survey at 3 Months After Enrollment

  Intervention feasibility, measured by the percentage of MSM index cases that respond to the follow-up survey 3 months after enrollment

  3 months post enrollment

• Acceptability Degree of the Intervention Using an Acceptability Questionnaire

  Intervention acceptability, measured by the mean score of an acceptability questionnaire among index patients in the intervention group at 3-month follow-up. The questionnaire asks index patients about their responses to statements regarding the acceptability of the crowdsourced intervention materials, and is rated on a 1-5 scale with mean scores ranging between 1 and 5, where 1 means 'strongly disagree' and 5 means 'strongly agree'. Higher mean scores mean higher acceptability.

  3 months post enrollment

• Percentage of Partners Who Perform HIV-testing Within 3 Months of the Index Patient's Enrollment

  The preliminary impact of the intervention, measured by the percentage of partners who perform HIV-testing within 3 months of the index patient's enrollment. Partner HIV testing is self-reported by the index, and verified by the partners uploading testing results.

  3 months post enrollment

Secondary Outcomes (6)

• Percentage of Partners Who Were Notified Within 3 Months of the Index's Enrollment

  3 months post enrollment

• Mean Number of Partners Tested Per Index

  3 months post enrollment

• Percentage of Partners Who Have Positive HIV Tests Among All Tested Partners

  3 months post enrollment

• Mean Number of Case-finding Per Index

  3 months post enrollment

• Percentage of Casual Male Partners Getting HIV Testing

  3 months post enrollment

Study Arms (2)

Crowdsourced HIV PS Group

EXPERIMENTAL

Participants in the intervention group will receive crowdsourced partner services intervention, including postcards from the crowdsourcing contest that promote PS, provider referral and dual referral services, and take-home HIV self testing kits.

Combination Product: Crowdsourced partner services intervention

Conventional HIV PS Group

NO INTERVENTION

Participants in the control group will receive traditional partner services intervention, including referral cards that encourage the index patient to notify their partners by themselves.

Interventions

Crowdsourced partner services intervention COMBINATION_PRODUCT

The intervention includes the provision of provider referral and dual referral services, crowdsourced materials such as postcards and an HTML aiming to promote PS, as well as free take-home HIV self-testing kits.

Crowdsourced HIV PS Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• born biologically male,
• aged 18 years old or older,
• newly identified as HIV positive,
• had oral or anal sex with a man,
• had at least one sexual partner in the previous 6 months
• live in Guangzhou

You may not qualify if:

• Not given informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Guangzhou Center for Diseases Control and Prevention

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Yan X, Tucker JD, Miller WC, Xu H, Zhou Y, Gu Y, Chen M, Liang M, Lu J, Zhan L, Tang W. Crowdsourced Partner Services Among Men Who Have Sex With Men Living With HIV: A Pilot Randomized Controlled Trial in China. Sex Transm Dis. 2024 Oct 1;51(10):673-680. doi: 10.1097/OLQ.0000000000001989. Epub 2024 May 1.

  PMID: 38691408 DERIVED

Results Point of Contact

• Title: Ms. Xumeng Yan
• Organization: University of North Carolina at Chapel Hill Project - China

xumeng_yan@seshglobal.org

+8615330225941

Study Officials

• Weiming Tang, Ph.D

  University of North Carolina Project-China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 120 newly identified MSM HIV cases will be randomly assigned into two groups in 2:1 ratio (intervention: control) and receive crowdsourced PS and conventional PS, respectively.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 22, 2021
• Study Start: August 1, 2021
• Primary Completion: August 15, 2022
• Study Completion: September 30, 2022
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: The investigator who proposes to use the data needs to have approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

CN (1)