Trial Outcomes & Findings for Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men (NCT NCT04772469)
NCT ID: NCT04772469
Last Updated: 2025-04-29
Results Overview
Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
934 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2025-04-29
Participant Flow
Between June 2021 and March 2022, we enumerated 1,509 fishermen in three beach communities. Among these fishermen, 934 were mapped to social networks and comprised the intent-to-treat sample. Of these, 733 men were reached and completed a baseline survey.
Unit of analysis: social network clusters
Participant milestones
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Overall Study
STARTED
|
453 77
|
481 79
|
|
Overall Study
Individuals
|
374 76
|
359 79
|
|
Overall Study
COMPLETED
|
353 74
|
313 76
|
|
Overall Study
NOT COMPLETED
|
100 3
|
168 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Baseline characteristics by cohort
| Measure |
Intervention: Promoter Training, Multiple HIV Self-test Kit Distribution, and Incentive Distribution
n=76 Social network clusters
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Control: Promoter Training and Referral for Testing
n=79 Social network clusters
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
Total
n=155 Social network clusters
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
366 Participants
n=39 Participants
|
352 Participants
n=41 Participants
|
718 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Age, Continuous
|
34.5 Years
n=39 Participants
|
37.2 Years
n=41 Participants
|
35.5 Years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
374 Participants
n=39 Participants
|
359 Participants
n=41 Participants
|
733 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
374 Participants
n=39 Participants
|
359 Participants
n=41 Participants
|
733 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Kenya
|
374 Participants
n=39 Participants
|
359 Participants
n=41 Participants
|
733 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: We used cluster adjusted means
Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
Outcome measures
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=353 Participants
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=313 Participants
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Self-reported HIV Testing
|
65.6 percentage of participants
Interval 59.5 to 71.7
|
31.3 percentage of participants
Interval 25.4 to 37.2
|
PRIMARY outcome
Timeframe: Up to 3 monthsThe percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline
Outcome measures
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=374 Participants
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=359 Participants
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months
|
67.3 percentage of participants
Interval 61.2 to 73.5
|
15.6 percentage of participants
Interval 10.9 to 20.2
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: We used cluster adjusted means, thus the value does not yield a whole number of participants.
Percentage of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening (combined)
Outcome measures
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=257 Participants
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=57 Participants
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Linkage to PrEP
|
19.7 percentage
Interval 13.6 to 25.8
|
19.6 percentage
Interval 9.24 to 30.1
|
SECONDARY outcome
Timeframe: Up to 6 monthsPrEP: Percentage of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of \>= 1500 ng/mL) at 6 months following PrEP initiation.
Outcome measures
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=70 Participants
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=30 Participants
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Adherence to PrEP (% With Detectable Tenofovir in the Urine)
|
18.7 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsART: Percentage of HIV-positive participants who attain viral suppression (HIV RNA \<400 c/mL), 6 months following ART initiation.
Outcome measures
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=84 Participants
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=82 Participants
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Adherence to ART
|
35.7 percentage of participants
Interval 25.2 to 46.3
|
40.2 percentage of participants
Interval 27.0 to 53.4
|
Adverse Events
Promoter Training, Multiple Self-test Kits, and Incentives
Serious events: 14 serious events
Other events: 1 other events
Deaths: 14 deaths
Short Training and Referral for Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=374 participants at risk
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=359 participants at risk
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
General disorders
Death
|
3.7%
14/374 • Number of events 14 • Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.
Same definition
|
0.00%
0/359 • Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.
Same definition
|
Other adverse events
| Measure |
Promoter Training, Multiple Self-test Kits, and Incentives
n=374 participants at risk
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
|
Short Training and Referral for Testing
n=359 participants at risk
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.27%
1/374 • Number of events 1 • Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.
Same definition
|
0.00%
0/359 • Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.
Same definition
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place