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

NCT ID: NCT04971967

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-09-30

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.

Detailed Description

This is a pilot RCT, and the primary outcomes of this study are: 1) to test the feasibility and acceptability of the crowdsourced intervention, and 2) to pilot the preliminary impact of crowdsourced PS intervention in promoting HIV testing among partners of the newly identified HIV cases. In addition, this pilot RCT aimed to collect preliminary data for the designing of a full RCT, which aimed to measure the efficacy of the crowdsourced PS intervention in promoting PS. Thus, the sample size of this study is not designed and will be not powered enough to test the difference between the two arms. However, with a sample size of 120 (80 for intervention arm and 40 for the control arm, respectively), this pilot study would be able to observe the differences between the two arms and collect preliminary data for adequate sample size calculation of a full RCT. With a sample size of 120 (ratio of 2:1), alpha=0.05, power=0.80, and the partner return rate in the conventional PS arm is 30% (around 31% in 2016 in Guangzhou), the minimal detectable effect size would be 26.7% for this pilot study.

Data analyses: For the primary outcomes of feasibility and acceptability of the intervention: this will be analyzed through descriptive analysis to assess the feedback on the feasibility and acceptability of the crowdsourced PS intervention at baseline and the follow-up survey. For the primary outcome of the proportion of partners returning for HIV testing within 2 months of the index participant's enrolment in the study, log-binomial regression (generalized linear model with binomial distribution and log link) will be used to calculate 95% confidence intervals for the proportion of notifiable partners visiting by arm. Risk differences and risk ratios will also be calculated in these models. As this study is a pilot RCT, adjustment for covariates is not necessary and will not be conducted in the primary analysis. In secondary analyses, pre-specified potential confounding variables will be adjusted that might bias the estimate if not accounted for (e.g. index age, index marital status). If a partner reports more than one index referred him, he will be counted as a returning partner for each identified index.

Subgroup analyses will be performed by partner sex, partner type (e.g. main male partner vs. casual male partner) and sexual orientation. Time to presentation will also be assessed among all notifiable partners using Cox proportional hazards with a robust variance estimator. In the time-to-event analyses, censoring will occur at the end of 2-months. Note that for the primary outcome, the assumption is that any partner without an identifiable record at the community center or in the centralized electronic medical record (EMR) did not present for HIV testing. Therefore, this study assumes no missing outcome data. Sensitivity analyses will be conducted using alternative definitions of presentation for testing, including using the self-reported data from index cases and partners. For count variables expressed as the mean number of partners, the investigators will use either Poisson regression or negative binomial regression if overdispersion is identified.

Conditions

Contact Tracing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Crowdsourced HIV PS Group

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.

Group Type: EXPERIMENTAL

Crowdsourced partner services intervention

Intervention Type: 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.

Conventional HIV PS Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Crowdsourced partner services intervention

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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

• Not given informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiming Tang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Project-China

Locations

Guangzhou Center for Diseases Control and Prevention

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38691408 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R34MH119963

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0496

Identifier Type: -

Identifier Source: org_study_id