Trial Outcomes & Findings for Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV (NCT NCT04971967)
NCT ID: NCT04971967
Last Updated: 2023-06-09
Results Overview
Intervention feasibility, measured by the percentage of MSM index cases that respond to the follow-up survey 3 months after enrollment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
3 months post enrollment
Results posted on
2023-06-09
Participant Flow
Three HIV testing clinics were selected as recruitment sites; they were based at Guangzhou CDC, an MSM CBO in Guangzhou, and an MSM CBO in Zhuhai, respectively. The baseline recruitment lasted from August 1st 2021 to May 26th 2022.
Participant milestones
| Measure |
Crowdsourced HIV PS Group
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
Participants in the control group will receive traditional partner services intervention, which uses referral cards that encourage the index patient to notify their partners by themselves.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
40
|
|
Overall Study
COMPLETED
|
75
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Crowdsourced HIV PS Group
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
Participants in the control group will receive traditional partner services intervention, which uses referral cards that encourage the index patient to notify their partners by themselves.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
Baseline Characteristics
Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV
Baseline characteristics by cohort
| Measure |
Crowdsourced HIV PS Group
n=81 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=40 Participants
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.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
31.0 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
30.2 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
81 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
81 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Sexual orientation
Gay
|
56 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sexual orientation
Straight
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sexual orientation
Bisexual
|
18 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sexual orientation
Other/Prefer not to answer
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sexual orientation disclosure
Yes
|
64 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sexual orientation disclosure
No
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post enrollmentIntervention feasibility, measured by the percentage of MSM index cases that respond to the follow-up survey 3 months after enrollment
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=81 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=40 Participants
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.
|
|---|---|---|
|
Percentage of MSM Index Cases That Respond to the Follow-up Survey at 3 Months After Enrollment
|
92.6 percentage of participants
Interval 84.8 to 96.6
|
82.5 percentage of participants
Interval 68.1 to 91.3
|
PRIMARY outcome
Timeframe: 3 months post enrollmentPopulation: Only indexes in the intervention arm who completed the 3-month follow-up survey would provide acceptability data.
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.
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=75 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
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.
|
|---|---|---|
|
Acceptability Degree of the Intervention Using an Acceptability Questionnaire
|
4.4 score on a scale
Standard Deviation 1.1
|
—
|
PRIMARY outcome
Timeframe: 3 months post enrollmentPopulation: 81 indexes in the intervention arm reported 171 sexual partners in total, and 40 indexes in the control arm reported 89 sexual partners in total.
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.
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=171 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=89 Participants
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.
|
|---|---|---|
|
Percentage of Partners Who Perform HIV-testing Within 3 Months of the Index Patient's Enrollment
|
38.0 percentage of partners
Interval 31.1 to 45.5
|
27.0 percentage of partners
Interval 18.8 to 37.0
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: 81 indexes in the intervention arm reported 171 sexual partners, and 40 indexes in the control arm reported 89 sexual partners.
The percentage of partners who were notified by their indexes within 3 months of the index's enrollment
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=171 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=89 Participants
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.
|
|---|---|---|
|
Percentage of Partners Who Were Notified Within 3 Months of the Index's Enrollment
|
34.5 percentage of partners
Interval 27.8 to 41.9
|
28.1 percentage of partners
Interval 19.8 to 38.2
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: Only index participants who finished the 3-month follow-up survey were included for analysis, including 75 out of 81 participants in the intervention group, and 33 out of 40 participants in the control group.
The mean number of sexual partners tested per index followed for the last 3 months.
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=75 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Number of Partners Tested Per Index
|
0.9 tested partners per index
Standard Deviation 1.3
|
0.7 tested partners per index
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: 65 sexual partners received HIV testing in the intervention group, and 24 sexual partners received HIV testing in the control group.
The percentage of partners tested as HIV positive among partners who performed HIV-testing in the last 3 months.
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=65 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=24 Participants
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.
|
|---|---|---|
|
Percentage of Partners Who Have Positive HIV Tests Among All Tested Partners
|
23.1 percentage of partners
Interval 14.5 to 34.6
|
12.5 percentage of partners
Interval 4.3 to 31.0
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: Only index participants who finished the 3-month follow-up survey were included for analysis, including 75 out of 81 participants in the intervention group, and 33 out of 40 participants in the control group.
The mean number of case-finding (i.e., partners tested positive) per index within 3 months post index enrollment
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=75 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Number of Case-finding Per Index
|
0.2 positive partners per index
Standard Deviation 0.4
|
0.1 positive partners per index
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: Only casual male partners reported by index participants were included in this analysis, including 110 casual male partners from the intervention group and 58 partners from the control group.
The percentage of partners getting HIV testing who are not spouses or regular male partners
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=110 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=58 Participants
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.
|
|---|---|---|
|
Percentage of Casual Male Partners Getting HIV Testing
|
21.8 percentage of casual male partners
Interval 15.1 to 30.4
|
10.3 percentage of casual male partners
Interval 4.8 to 20.8
|
SECONDARY outcome
Timeframe: 3 months post enrollmentPopulation: Only 24 partners in the intervention group and 6 partners in the control group completed the partner survey that asked about their 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
Outcome measures
| Measure |
Crowdsourced HIV PS Group
n=24 Participants
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=6 Participants
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.
|
|---|---|---|
|
Percentage of Presenting Partners Reporting Condom Use During the Last Anal Intercourse
|
62.5 percentage of presenting partners
Interval 42.7 to 78.8
|
33.3 percentage of presenting partners
Interval 9.7 to 70.0
|
Adverse Events
Crowdsourced HIV PS Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conventional HIV PS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crowdsourced HIV PS Group
n=81 participants at risk
Participants in the intervention group will receive crowdsourced HIV partner services that integrated three parts: (a) educational materials for HIV PS promotion purposes, (b) secondary distribution of HIVST kits (HIVST-SD) to sexual partners, and (c) options of provider referral or contract referral using anonymous notification messages.
The educational materials included (a.1) postcards from previous crowdsourcing events to facilitate HIV PS, and (a.2) a digital platform embedded in the WeChat application that offered HIV PS skills by partner types, and potential risks or adverse consequences. The digital platform also included a section on peer sharing, where MLWH shared their experience of successfully disclosing their HIV status to their sexual partners in text or video forms. The QR code of the digital platform was printed on (a.3) a public transport card pre-charged with $3 for portable usage and easy access.
|
Conventional HIV PS Group
n=40 participants at risk
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.
|
|---|---|---|
|
Social circumstances
Negative consequences after HIV PS
|
1.2%
1/81 • Number of events 1 • From the time of signing the Informed Consent through follow up, a total of approximately 3 months
Adverse events are defined as an index reporting negative consequences after HIV disclosure to sexual partners, such as suffering violence.
|
0.00%
0/40 • From the time of signing the Informed Consent through follow up, a total of approximately 3 months
Adverse events are defined as an index reporting negative consequences after HIV disclosure to sexual partners, such as suffering violence.
|
Additional Information
Ms. Xumeng Yan
University of North Carolina at Chapel Hill Project - China
Phone: +8615330225941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place