Trial Outcomes & Findings for A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs (NCT NCT00183456)
NCT ID: NCT00183456
Last Updated: 2013-06-28
Results Overview
Number of participants that had 2 or more sex partners in the past 90 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
746 participants
Primary outcome timeframe
6 months
Results posted on
2013-06-28
Participant Flow
The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007
Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.
Participant milestones
| Measure |
Intervention Condition: CHAT
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
84
|
329
|
248
|
|
Overall Study
6 Month Follow-up
|
74
|
77
|
278
|
175
|
|
Overall Study
12 Month Follow-up
|
76
|
74
|
267
|
186
|
|
Overall Study
18 Month Follow-up
|
80
|
81
|
303
|
207
|
|
Overall Study
COMPLETED
|
82
|
83
|
313
|
220
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
16
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Baseline characteristics by cohort
| Measure |
Intervention Condition: CHAT
n=85 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=84 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=329 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=248 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
323 Participants
n=206 Participants
|
247 Participants
n=7 Participants
|
739 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Age Continuous
|
42.1 years
STANDARD_DEVIATION 7 • n=99 Participants
|
43.3 years
STANDARD_DEVIATION 7 • n=107 Participants
|
42.9 years
STANDARD_DEVIATION 10 • n=206 Participants
|
40.6 years
STANDARD_DEVIATION 8 • n=7 Participants
|
42 years
STANDARD_DEVIATION 9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
248 Participants
n=7 Participants
|
567 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
179 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=99 Participants
|
84 participants
n=107 Participants
|
329 participants
n=206 Participants
|
248 participants
n=7 Participants
|
746 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants that had 2 or more sex partners in the past 90 days.
Outcome measures
| Measure |
Intervention Condition: CHAT
n=73 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=75 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=277 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=174 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
|
17 participants
|
29 participants
|
50 participants
|
53 participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=76 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=74 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=264 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=185 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
|
10 participants
|
22 participants
|
47 participants
|
58 participants
|
PRIMARY outcome
Timeframe: 18 monthOutcome measures
| Measure |
Intervention Condition: CHAT
n=80 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=299 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=205 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
|
5 participants
|
18 participants
|
43 participants
|
35 participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=80 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=299 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=205 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
|
32 participants
|
49 participants
|
123 participants
|
119 participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=80 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=299 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=205 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
|
30 participants
|
50 participants
|
127 participants
|
113 participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=80 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=299 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=205 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
|
8 participants
|
21 participants
|
47 participants
|
51 participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=80 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=299 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=205 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
|
51 participants
|
69 participants
|
172 participants
|
151 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=73 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=77 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=277 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=173 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
|
61 participants
|
52 participants
|
155 participants
|
117 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=76 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=74 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=264 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=184 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
|
58 participants
|
39 participants
|
124 participants
|
104 participants
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Intervention Condition: CHAT
n=78 Participants
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
|
Comparison Condition: Standard of Care
n=81 Participants
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
|
Network Participants
n=291 Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
|
Non-randomized Baseline Index Participants
n=202 Participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
|
|---|---|---|---|---|
|
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
|
56 participants
|
42 participants
|
141 participants
|
113 participants
|
Adverse Events
Intervention Condition: CHAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison Condition: Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Network Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-randomized Baseline Index Participants
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