Trial Outcomes & Findings for The Shauriana Intervention for GBMSM in Kenya (NCT NCT04550221)
NCT ID: NCT04550221
Last Updated: 2025-03-20
Results Overview
All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Month 6
Results posted on
2025-03-20
Participant Flow
Screening and enrollment took lace between May 10 and September 8 2021 at the Anza Mapema Clinic in Kisumu, Kenya. Overall, 71 individuals were screened, of whom 11 were not eligible. Sixty-three individuals were enrolled and completed a baseline visit.
Three individuals who were assigned to the intervention arm were withdrawn from the study after the baseline visit because they moved immediately from the study area or otherwise turned out not to be available for study and/or intervention visits.
Participant milestones
| Measure |
Intervention
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
Month 1 Visit
|
29
|
31
|
|
Overall Study
Month 3 Visit
|
29
|
30
|
|
Overall Study
Month 6 Visit
|
27
|
27
|
|
Overall Study
Exit Interviews
|
28
|
0
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Intervention
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Withdrawn
|
3
|
0
|
|
Overall Study
Moved from the study area after receiving the intervention
|
2
|
0
|
Baseline Characteristics
The Shauriana Intervention for GBMSM in Kenya
Baseline characteristics by cohort
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
n=31 Participants
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
26 years
n=7 Participants
|
25 years
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
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Kenyan
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Ever married to a female
No
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ever married to a female
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
Completed primary school
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Completed secondary school
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
Completed certificate, diploma, or degree
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Education
Current student
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex of partners in past 3 months
Male only
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex of partners in past 3 months
Male and female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Condom use last sex
Yes
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Condom use last sex
No
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Exit interviews only offered to intervention participants
All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview
Outcome measures
| Measure |
Intervention
n=28 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
Completion of Exit Interview
|
28 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: Intervention feasibility was only assessed in the intervention group
Intervention session attendance
Outcome measures
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
Intervention Feasibility
Completed all 5 intervention sessions only
|
11 Participants
|
0 Participants
|
|
Intervention Feasibility
Completed all 5 intervention sessions plus an optional session
|
18 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 6Adverse events reported by participants
Outcome measures
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
n=31 Participants
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
Intervention Safety
Adverse events reported
|
0 Participants
|
0 Participants
|
|
Intervention Safety
Adverse events not reported
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Month 1, Month 3, and Month 6Ongoing PrEP use (yes or no) assessed by ACASI
Outcome measures
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
n=31 Participants
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
PrEP Uptake
Month 1 · Used PrEP since last visit
|
16 Participants
|
14 Participants
|
|
PrEP Uptake
Month 1 · Did not use PrEP since last visit
|
12 Participants
|
15 Participants
|
|
PrEP Uptake
Month 1 · Missed visit or missing data
|
1 Participants
|
2 Participants
|
|
PrEP Uptake
Month 3 · Used PrEP since last visit
|
17 Participants
|
18 Participants
|
|
PrEP Uptake
Month 3 · Did not use PrEP since last visit
|
11 Participants
|
12 Participants
|
|
PrEP Uptake
Month 3 · Missed visit or missing data
|
1 Participants
|
1 Participants
|
|
PrEP Uptake
Month 6 · Used PrEP since last visit
|
11 Participants
|
13 Participants
|
|
PrEP Uptake
Month 6 · Did not use PrEP since last visit
|
16 Participants
|
14 Participants
|
|
PrEP Uptake
Month 6 · Missed visit or missing data
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Month 1, Month 3, and Month 6In the last 30 days, how good a job did you do at taking your PrEP daily?
Outcome measures
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
n=31 Participants
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
PrEP Adherence
Month 1 · Poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence
Month 1 · Fair
|
0 Participants
|
1 Participants
|
|
PrEP Adherence
Month 1 · Good
|
5 Participants
|
7 Participants
|
|
PrEP Adherence
Month 1 · Very good
|
4 Participants
|
2 Participants
|
|
PrEP Adherence
Month 1 · Excellent
|
2 Participants
|
0 Participants
|
|
PrEP Adherence
Month 1 · Missing or not taking PrEP
|
18 Participants
|
21 Participants
|
|
PrEP Adherence
Month 3 · Poor
|
1 Participants
|
0 Participants
|
|
PrEP Adherence
Month 3 · Fair
|
2 Participants
|
7 Participants
|
|
PrEP Adherence
Month 3 · Good
|
5 Participants
|
6 Participants
|
|
PrEP Adherence
Month 3 · Very good
|
2 Participants
|
2 Participants
|
|
PrEP Adherence
Month 3 · Excellent
|
2 Participants
|
2 Participants
|
|
PrEP Adherence
Month 3 · Missing or not taking PrEP
|
17 Participants
|
14 Participants
|
|
PrEP Adherence
Month 6 · Poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence
Month 6 · Fair
|
1 Participants
|
3 Participants
|
|
PrEP Adherence
Month 6 · Good
|
4 Participants
|
3 Participants
|
|
PrEP Adherence
Month 6 · Very good
|
0 Participants
|
3 Participants
|
|
PrEP Adherence
Month 6 · Excellent
|
2 Participants
|
2 Participants
|
|
PrEP Adherence
Month 6 · Missing or not taking PrEP
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Tenofovir levels measured in dried blood spots
Outcome measures
| Measure |
Intervention
n=29 Participants
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
Shauriana: The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
|
Standard Care
n=31 Participants
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
|
|---|---|---|
|
PrEP Drug Levels
Month 3 · Missing
|
3 Participants
|
1 Participants
|
|
PrEP Drug Levels
Month 3 · TFV-DP detected
|
3 Participants
|
7 Participants
|
|
PrEP Drug Levels
Month 3 · TFV-DP not detected
|
23 Participants
|
23 Participants
|
|
PrEP Drug Levels
Month 6 · TFV-DP detected
|
4 Participants
|
6 Participants
|
|
PrEP Drug Levels
Month 6 · TFV-DP not detected
|
22 Participants
|
21 Participants
|
|
PrEP Drug Levels
Month 6 · Missing
|
3 Participants
|
4 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
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