Trial Outcomes & Findings for Mobile Health Intervention to Increase HIV Testing and Linkage to Care (NCT NCT05484895)
NCT ID: NCT05484895
Last Updated: 2025-11-05
Results Overview
HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1800 participants
Primary outcome timeframe
Months 6, 12, and 18
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
WeTest-WeLink intervention
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Overall Study
STARTED
|
900
|
900
|
|
Overall Study
COMPLETED
|
837
|
836
|
|
Overall Study
NOT COMPLETED
|
63
|
64
|
Reasons for withdrawal
| Measure |
WeTest-WeLink intervention
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
63
|
64
|
Baseline Characteristics
Mobile Health Intervention to Increase HIV Testing and Linkage to Care
Baseline characteristics by cohort
| Measure |
WeTest-WeLink intervention
n=900 Participants
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
n=900 Participants
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
Total
n=1800 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
900 Participants
n=15 Participants
|
900 Participants
n=161 Participants
|
1800 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Region of Enrollment
China
|
900 Participants
n=15 Participants
|
900 Participants
n=161 Participants
|
1800 Participants
n=100 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Customized
18-24 years
|
224 Participants
n=15 Participants
|
228 Participants
n=161 Participants
|
452 Participants
n=100 Participants
|
|
Age, Customized
25-39 years
|
509 Participants
n=15 Participants
|
511 Participants
n=161 Participants
|
1020 Participants
n=100 Participants
|
|
Age, Customized
>=40 years
|
147 Participants
n=15 Participants
|
161 Participants
n=161 Participants
|
308 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
900 Participants
n=15 Participants
|
900 Participants
n=161 Participants
|
1800 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
900 Participants
n=15 Participants
|
900 Participants
n=161 Participants
|
1800 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Months 6, 12, and 18HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.
Outcome measures
| Measure |
WeTest-WeLink intervention
n=900 Participants
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
n=900 Participants
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Number of Participants Completing HIV Self-Testing
Month 6
|
878 Participants
|
889 Participants
|
|
Number of Participants Completing HIV Self-Testing
Month 12
|
857 Participants
|
875 Participants
|
|
Number of Participants Completing HIV Self-Testing
Month 18
|
837 Participants
|
836 Participants
|
SECONDARY outcome
Timeframe: Months 6, 12, and 18Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of laboratory test results of cluster of differentiation 4 (CD4) and HIV viral load.
Outcome measures
| Measure |
WeTest-WeLink intervention
n=900 Participants
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
n=900 Participants
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Number of Participants With HIV Laboratory Test Results
Month 6
|
3 Participants
|
6 Participants
|
|
Number of Participants With HIV Laboratory Test Results
Month 12
|
6 Participants
|
5 Participants
|
|
Number of Participants With HIV Laboratory Test Results
Month 18
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Months 6, 12, and 18Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of attendance at an initial HIV care appointment with a local provider.
Outcome measures
| Measure |
WeTest-WeLink intervention
n=900 Participants
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
n=900 Participants
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Number of Participants Attending Initial HIV Care Appointment
Month 6
|
3 Participants
|
6 Participants
|
|
Number of Participants Attending Initial HIV Care Appointment
Month 12
|
6 Participants
|
5 Participants
|
|
Number of Participants Attending Initial HIV Care Appointment
Month 18
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Months 6, 12, and 18Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of receipt of an HIV confirmatory test.
Outcome measures
| Measure |
WeTest-WeLink intervention
n=900 Participants
Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.
WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.
|
Control
n=900 Participants
Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.
Control condition: Contact information of local NGO for emergency referrals; free additional HST.
|
|---|---|---|
|
Number of Participants Receiving Receipt of HIV Confirmatory Test
Month 6
|
3 Participants
|
6 Participants
|
|
Number of Participants Receiving Receipt of HIV Confirmatory Test
Month 12
|
6 Participants
|
5 Participants
|
|
Number of Participants Receiving Receipt of HIV Confirmatory Test
Month 18
|
3 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 6, 12, and 18Participants are asked to report whether or not they have used any HIV prevention services.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 6, 12, and 18HIV risk behavior is assessed by participants self-reporting alcohol or drug use prior to or during sexual episodes during the past 3 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 6, 12, and 18HIV sexual risk is assessed as participants' self-report of condomless anal sex.
Outcome measures
Outcome data not reported
Adverse Events
WeTest-WeLink intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place