Contact TracingNCT04971967
Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV
A study testing Crowdsourced partner services intervention in people with Contact Tracing, run by University of North Carolina, Chapel Hill at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Contact Tracing
- What is being tested?
- Crowdsourced partner services intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meet inclusion criteria
- Not given informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Center for Diseases Control and Prevention
Guangzhou, Guangdong
About this study
Official title: Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV: A Pilot Randomized Controlled Trial
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.
Read the 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
- Being tested
- Crowdsourced partner services intervention
- Keywords
- Partner notification services, Crowdsourcing, MSM, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crowdsourced partner services interventionCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 3 months post enrollment
Secondary outcomes (6)
Percentage of Partners Who Were Notified Within 3 Months of the Index's Enrollment
The percentage of partners who were notified by their indexes within 3 months of the index's enrollment
Measured: 3 months post enrollment
Mean Number of Partners Tested Per Index
The mean number of sexual partners tested per index followed for the last 3 months.
Measured: 3 months post enrollment
Percentage of Partners Who Have Positive HIV Tests Among All Tested Partners
The percentage of partners tested as HIV positive among partners who performed HIV-testing in the last 3 months.
Measured: 3 months post enrollment
Mean Number of Case-finding Per Index
The mean number of case-finding (i.e., partners tested positive) per index within 3 months post index enrollment
Measured: 3 months post enrollment
Percentage of Casual Male Partners Getting HIV Testing
The percentage of partners getting HIV testing who are not spouses or regular male partners
Measured: 3 months post enrollment
Percentage of Presenting Partners Reporting Condom Use During the Last Anal Intercourse
The percentage of presenting partners who completed the partner survey and reported condom use during the last anal intercourse
Measured: 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Aug 2021
- Primary completion15 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact TracingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Weiming Tang, Ph.D, Principal investigator, University of North Carolina Project-China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971967
- Sponsor's protocol ID
- 19-0496
- Other IDs
- R34MH119963
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2021
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
Publications
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.
PubMed 38691408
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04971967
- Acronym / sponsor ID
- 19-0496
- Conditions
- Contact Tracing
- Keywords
- Partner notification services, Crowdsourcing, MSM, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Crowdsourced HIV PS Group | Experimental | Combination Product: Crowdsourced partner services interventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Not meet inclusion criteria
- Not given informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crowdsourced partner services interventionThe 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. | Combination product | Crowdsourced HIV PS Group |
Primary outcome
Percentage of MSM Index Cases That Respond to the Follow-up Survey at 3 Months After Enrollment
Time frame: 3 months post enrollment
Intervention feasibility, measured by the percentage of MSM index cases that respond to the follow-up survey 3 months after enrollment
Acceptability Degree of the Intervention Using an Acceptability Questionnaire
Time frame: 3 months post enrollment
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.
Percentage of Partners Who Perform HIV-testing Within 3 Months of the Index Patient's Enrollment
Time frame: 3 months post 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.
6 secondary outcomes
Percentage of Partners Who Were Notified Within 3 Months of the Index's Enrollment
Time frame: 3 months post enrollment
Mean Number of Partners Tested Per Index
Time frame: 3 months post enrollment
Percentage of Partners Who Have Positive HIV Tests Among All Tested Partners
Time frame: 3 months post enrollment
Mean Number of Case-finding Per Index
Time frame: 3 months post enrollment
Percentage of Casual Male Partners Getting HIV Testing
Time frame: 3 months post enrollment
Percentage of Presenting Partners Reporting Condom Use During the Last Anal Intercourse
Time frame: 3 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38691408Yan 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiming Tang, Ph.D principal investigator
University of North Carolina Project-China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crowdsourced partner services intervention in people with Contact Tracing, run by University of North Carolina, Chapel Hill at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of MSM Index Cases That Respond to the Follow-up Survey at 3 Months After Enrollment (time frame: 3 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.