Trial Outcomes & Findings for Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men (NCT NCT04135443)
NCT ID: NCT04135443
Last Updated: 2024-11-15
Results Overview
Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
3-months post baseline
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
3T Tune in! Turn on! Turn up!
The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum. Participants were randomly assigned individually to arms.
|
General Health Website Materials
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster). Participants were randomly assigned individually to study arms.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
89
|
|
Overall Study
COMPLETED
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men
Baseline characteristics by cohort
| Measure |
3T Tune in! Turn on! Turn up!
n=89 Participants
The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=89 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.28 Years
STANDARD_DEVIATION 1.18 • n=5 Participants
|
18.20 Years
STANDARD_DEVIATION 1.25 • n=7 Participants
|
18.23 Years
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Engaged in condomless receptive or insertive anal or condomless vaginal intercourse last 3 months
|
57 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-months post baselinePopulation: All participants with complete data on baseline and follow-up survey.
Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=74 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=74 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Condomless Anal Intercourse or Condomless Vaginal Intercourse
|
49 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 3-months post baseline\# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-months post baselinePopulation: Participants with complete data on baseline and follow-up for outcome.
Number of times reported having been tested for STI, including HIV in the last 3 months
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=49 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=47 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Self-reported STI/HIV Testing in Last Three Months
|
1.04 Times tested, self reported
Standard Deviation 1.70
|
0.60 Times tested, self reported
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 3-months post baselinePopulation: Participants with complete data on baseline and follow-up survey for outcome.
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 1 - 5, with a higher score indicating better outcomes
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=73 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=70 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Dyadic Communication Scale
|
3.22 score on a scale
Standard Deviation 0.62
|
3.22 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: 3-months post baselinePopulation: Participants with complete baseline and follow-up survey data for outcome.
Scale measures attitudes regarding condoms. Average of 21 items on a 4-point scale (1 to 4), with a range of 1 - 4, with a higher score indicating better outcomes
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=69 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=68 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Condom Attitudes Scale
|
3.02 score on a scale
Standard Deviation 0.50
|
2.90 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 3-months post baselinePopulation: Participants with complete data on baseline and follow-up survey for outcome.
Scale measures perceived self-efficacy to use condoms. Average of 4 items on a 4-point scale (1 to 4), with a range of 1 - 4, with a higher score indicating better outcomes
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=70 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=67 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Condom Self-Efficacy Scale
|
3.21 score on a scale
Standard Deviation 0.69
|
3.07 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 3-months post baselinePopulation: Participants with complete data on baseline and follow-up survey for outcome.
Scale measures attitudes towards lube. Average of 3 items on a 4-point scale (1-4), with a range of 1-4, with a higher score indicating more positive attitudes towards lube
Outcome measures
| Measure |
3T Tune in! Turn on! Turn up!
n=72 Participants
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum.
|
General Health Website Materials
n=69 Participants
The control intervention featured a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).
|
|---|---|---|
|
Attitudes Towards Lube
|
3.40 score on a scale
Standard Deviation 0.63
|
3.40 score on a scale
Standard Deviation 0.60
|
Adverse Events
3T Tune in! Turn on! Turn up!
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Health Website Materials
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
Tamara Kuhn, Vice President and Research Scientist
dfusion, Inc
Phone: 831-222-5003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place