Trial Outcomes & Findings for Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment (NCT NCT03678181)
NCT ID: NCT03678181
Last Updated: 2024-09-27
Results Overview
The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
750 participants
Primary outcome timeframe
12 month
Results posted on
2024-09-27
Participant Flow
Participant milestones
| Measure |
Information-Only Arm
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
|---|---|---|---|
|
Overall Study
STARTED
|
332
|
333
|
85
|
|
Overall Study
COMPLETED
|
332
|
333
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment
Baseline characteristics by cohort
| Measure |
Information-Only Arm
n=332 Participants
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
n=333 Participants
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
n=85 Participants
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.72 years
STANDARD_DEVIATION 3.20 • n=5 Participants
|
24.62 years
STANDARD_DEVIATION 3.52 • n=7 Participants
|
26.18 years
STANDARD_DEVIATION 2.77 • n=5 Participants
|
24.84 years
STANDARD_DEVIATION 3.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
332 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
750 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
140 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
432 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
208 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
453 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
63 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
HIV Status
HIV negative
|
258 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
520 Participants
n=4 Participants
|
|
HIV Status
HIV positive
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthPopulation: HIV Testing outcome focuses on HIV-negative participants in the trial
The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Outcome measures
| Measure |
Information-Only Arm
n=258 Participants
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
n=258 Participants
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
n=4 Participants
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
|---|---|---|---|
|
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
|
185 Participants
|
171 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 12 monthThe investigators will estimate the proportion of participants living with HIV who achieve viral suppression over a 12-month period by intervention group.
Outcome measures
| Measure |
Information-Only Arm
n=74 Participants
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
n=75 Participants
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
n=81 Participants
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
|---|---|---|---|
|
Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires
Virally Suppressed
|
45 Participants
|
60 Participants
|
60 Participants
|
|
Percent of Participants Reporting Viral Suppression Using Self-Report Questionnaires
Not Virally Suppressed
|
29 Participants
|
15 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe investigators will test the proportion of the HIV-positive sample that adheres to their HIV care regimen during the 12-month follow-up.
Outcome measures
| Measure |
Information-Only Arm
n=40 Participants
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
n=53 Participants
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
n=51 Participants
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
|---|---|---|---|
|
Number of Days in the Prior Week That Participants Self-report Missing at Least One Dose of Their Adherence to Antiretroviral Therapy (ART) Using a Self-Reported Questionnaire
|
0.92 days
Standard Deviation 1.65
|
0.96 days
Standard Deviation 1.75
|
1.21 days
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: 12 monthThe investigators will test the proportion of the HIV-negative sample that reports using PrEP by the 12-month follow-up.
Outcome measures
| Measure |
Information-Only Arm
n=205 Participants
The HMP 2.0 Information-Only Control Arm will feature a streamlined version of the website that provides tailored information and content for YBLMT. This follows the design of HMP 1.0 where control arm participants had access to HIV-related Knowledge Center articles of the main intervention without access to the engagement features, interactive forums, or doctor Q\&A. HIV-negative and sero-unknown participants also will be able to request HIV home test kits. The choice of control arm balances equipoise with research study design; in HMP 1.0, control arm participants also experienced a statistically significant intervention benefit.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
HMP 2.0 Arm
n=189 Participants
Participants in this experimental arm will receive access to HMP 2.0, an interactive site that includes a Knowledge Center focused on HIV prevention content, interactive forums, and a provider question \& answer platform.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
Peer-referred HMP Network Arm
n=2 Participants
Participants randomized to Intervention Arm 2 (peer-created network) will be enrolled into a parallel (but separate) version of HMP 2.0. The only difference between the two intervention arms is that the peer-referred HMP network arm will allow participants to refer and enroll 2 peers of their choosing into the study.
Information Resources: The investigators will provide a HIV-related content as the attention-control condition.
Social Support: The investigators will provide evidence-based answers to users' health questions, including linkage to care.
HIV Testing: The investigators will provide opportunities for participants to get tested through HIV home test kits.
|
|---|---|---|---|
|
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
Yes, I am on PrEP right now
|
77 Participants
|
74 Participants
|
0 Participants
|
|
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
Yes, I was in the past, but I'm not on PrEP anymore
|
50 Participants
|
42 Participants
|
1 Participants
|
|
Percent of Participants Reporting PrEP Uptake Using Self-Report Questionnaires
No, I've never taken PrEP
|
78 Participants
|
73 Participants
|
1 Participants
|
Adverse Events
Information-Only Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HMP 2.0 Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer-referred HMP Network Arm
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