Trial Outcomes & Findings for Mobilizing Social Network Resources for HIV Care Support (NCT NCT05123274)
NCT ID: NCT05123274
Last Updated: 2026-08-20
Results Overview
Outcome 1 was self-reported number of HIV medical care appointments that participants attended in the previous 6 months, regardless of whether these appointments were scheduled or not, so even those who did not schedule any appointment were included as 0 appointments attended.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
6 months
Results posted on
2026-08-20
Participant Flow
The study was conducted in Midwestern mid-sized cities. Participants were recruited using a variety of methods. Potential participants were located through: (a) events at, or visits to, community organizations that serve sexual minority men and/or PLH; (b) community cultural gatekeepers/mediators who were knowledgeable about, and provided access to, HIV-positive, hard-to-reach PLH; and (c) online advertisements at online forums, chatrooms, and dating sites serving sexual minority men.
The actual number of enrolled participants was 94, slightly fewer than the originally-proposed number of 100 due to a limited recruitment period that resulted from site relocation (see Limitations and Caveats). Of these 94, half of participants (47) were randomized into one of the two conditions. The other half of enrolled participants (47) were impossible to locate prior to randomization, primarily due to their social circumstances (homelessness and lack of communication means such as phones).
Participant milestones
| Measure |
Individual Care Counseling
After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.
|
Social Support Mobilization
In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Individual Care Counseling
After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.
|
Social Support Mobilization
In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Mobilizing Social Network Resources for HIV Care Support
Baseline characteristics by cohort
| Measure |
Individual Care Counseling
n=24 Participants
After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.
|
Social Support Mobilization
n=23 Participants
In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
37.6 Years
STANDARD_DEVIATION 13.88 • n=109 Participants
|
39.6 Years
STANDARD_DEVIATION 13.56 • n=133 Participants
|
|
Sex/Gender, Customized
Males
|
23 Participants
n=5 Participants
|
21 Participants
n=109 Participants
|
44 Participants
n=133 Participants
|
|
Sex/Gender, Customized
Transgender females
|
1 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
23 Participants
n=109 Participants
|
47 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
21 Participants
n=109 Participants
|
45 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: There were 5 participants lost to follow-up. At the 6-month follow-up assessment 20 participants remained in the Individual Care Counseling Arm of the study, and 22 participants remained in the Social Support Mobilization Arm (see Participant Flow).
Outcome 1 was self-reported number of HIV medical care appointments that participants attended in the previous 6 months, regardless of whether these appointments were scheduled or not, so even those who did not schedule any appointment were included as 0 appointments attended.
Outcome measures
| Measure |
Individual Care Counseling
n=24 Participants
After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.
|
Social Support Mobilization
n=23 Participants
In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.
|
|---|---|---|
|
HIV Medical Appointments Kept
Baseline assessment
|
1.79 Number of visits in past 6 months
Standard Error 0.21
|
1.74 Number of visits in past 6 months
Standard Error 0.17
|
|
HIV Medical Appointments Kept
6-month follow-up assessment
|
1.70 Number of visits in past 6 months
Standard Error 0.28
|
1.64 Number of visits in past 6 months
Standard Error 0.26
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: There were 5 participants lost to follow-up. At the 6-month follow-up assessment 20 participants remained in the Individual Care Counseling Arm of the study, and 22 participants remained in the Social Support Mobilization Arm (see Participant Flow).
Outcome 2 was the calculated difference between the reported number of appointments scheduled in the past 6 months and the number of these scheduled appointments attended.
Outcome measures
| Measure |
Individual Care Counseling
n=24 Participants
After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.
|
Social Support Mobilization
n=23 Participants
In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.
|
|---|---|---|
|
HIV Medical Appointments Missed
6-month follow-up assessment
|
0.05 Number of care appointments not kept
Standard Error 0.04
|
0.18 Number of care appointments not kept
Standard Error 0.10
|
|
HIV Medical Appointments Missed
Baseline assessment
|
0.54 Number of care appointments not kept
Standard Error 0.13
|
0.61 Number of care appointments not kept
Standard Error 0.17
|
Adverse Events
Individual Care Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Social Support Mobilization
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