HIV Prevention
Conditions
Keywords
preexposure prophylaxis, sexual health, mental health, behavioral intervention
Brief summary
The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.
Detailed description
Gay, bisexual, and other men who have sex with men (GBMSM) are at high risk for HIV-1 acquisition, especially in rights-constrained settings such as Kenya, where men's access to HIV prevention has been impeded by homophobia, stigma, and discrimination. Pre-exposure prophylaxis (PrEP) has the potential to greatly reduce HIV acquisition risk in this key population if accessible, sustainable PrEP programming with tailored, effective adherence support can be provided. To this end, close collaboration between PrEP program implementers and GBMSM-led community-based organizations is essential. Based on preliminary qualitative work, this theory-based and culturally relevant PrEP support intervention is called Shauriana (Kiswahili for we counsel each other). The Shauriana intervention merges peer navigation and integrated Next Step Counseling (iNSC) to promote sexual health protection strategies, including PrEP uptake and adherence, among GBMSM in Kisumu. The present proposal aims to pilot the intervention among 10 participants for 3 months, and then to evaluate the Shauriana intervention for acceptability, feasibility, safety, and estimated effect on PrEP uptake and adherence, compared to standard of care, in a small randomized, controlled study with 60 participants followed for 6 months after enrollment. Results of the proposed research will have high impact by ensuring GBMSM involvement in the scale-up of effective PrEP programming for this key population in Kenya and providing a peer-led PrEP support model for GBMSM and other vulnerable and marginalized populations in African settings.
Interventions
BEHAVIORALShauriana
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).
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Laboratory testing for PrEP drug levels will be conducted in a blinded fashion
Intervention model description
Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Biologically male at birth and identifies as male, according to self-report * 18 to 35 years of age * Resident in the Kisumu area for ≥12 months * Reports anal intercourse with a man in the past 3 months * Not currently taking PrEP for HIV prevention in the past 3 months * Willing to provide complete locator information * Willing to undergo all study procedures, including HIV testing and counselling * Not currently participating in any HIV prevention or vaccine study * Planning to remain in the study area for at least 6 months For the pilot study only, men will be required to speak English, in order to expedite the study team's analysis of feedback from these participants in preparation for the randomized controlled trial (RCT). Of note, approximately 50%-60% of young MSM in Kisumu speak English.
Exclusion criteria
* Unable to understand the study purpose and procedures * Unwilling to adhere to study procedures * Currently under the influence of alcohol or drugs * Prior diagnosis of HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Exit Interview | Month 6 | All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview |
| Intervention Feasibility | Month 6 | Intervention session attendance |
| Intervention Safety | Month 6 | Adverse events reported by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake | Month 1, Month 3, and Month 6 | Ongoing PrEP use (yes or no) assessed by ACASI |
| PrEP Adherence | Month 1, Month 3, and Month 6 | In the last 30 days, how good a job did you do at taking your PrEP daily? |
| PrEP Drug Levels | Month 3 and Month 6 | Tenofovir levels measured in dried blood spots |
Countries
Kenya
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 29 |
| 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. | 31 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Moved from the study area after receiving the intervention | 2 | 0 |
| Overall Study | Withdrawn | 3 | 0 |
Baseline characteristics
| Characteristic | Intervention | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 24 years | 26 years | 25 years |
| Condom use last sex No | 2 Participants | 9 Participants | 11 Participants |
| Condom use last sex Yes | 27 Participants | 22 Participants | 49 Participants |
| Education Completed certificate, diploma, or degree | 8 Participants | 10 Participants | 18 Participants |
| Education Completed primary school | 1 Participants | 2 Participants | 3 Participants |
| Education Completed secondary school | 18 Participants | 15 Participants | 33 Participants |
| Education Current student | 2 Participants | 4 Participants | 6 Participants |
| Ever married to a female No | 28 Participants | 28 Participants | 56 Participants |
| Ever married to a female Yes | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Kenyan | 29 Participants | 31 Participants | 60 Participants |
| Region of Enrollment Kenya | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 29 Participants | 31 Participants | 60 Participants |
| Sex of partners in past 3 months Male and female | 14 Participants | 12 Participants | 26 Participants |
| Sex of partners in past 3 months Male only | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Completion of Exit Interview
All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview
Time frame: Month 6
Population: Exit interviews only offered to intervention participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Completion of Exit Interview | 28 Participants |
Primary
Intervention Feasibility
Intervention session attendance
Time frame: Month 6
Population: Intervention feasibility was only assessed in the intervention group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Intervention Feasibility | Completed all 5 intervention sessions only | 11 Participants |
| Intervention | Intervention Feasibility | Completed all 5 intervention sessions plus an optional session | 18 Participants |
| Standard Care | Intervention Feasibility | Completed all 5 intervention sessions only | 0 Participants |
| Standard Care | Intervention Feasibility | Completed all 5 intervention sessions plus an optional session | 0 Participants |
Primary
Intervention Safety
Adverse events reported by participants
Time frame: Month 6
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Intervention Safety | Adverse events reported | 0 Participants |
| Intervention | Intervention Safety | Adverse events not reported | 29 Participants |
| Standard Care | Intervention Safety | Adverse events reported | 0 Participants |
| Standard Care | Intervention Safety | Adverse events not reported | 31 Participants |
Secondary
PrEP Adherence
In the last 30 days, how good a job did you do at taking your PrEP daily?
Time frame: Month 1, Month 3, and Month 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | PrEP Adherence | Month 1 | Poor | 0 Participants |
| Intervention | PrEP Adherence | Month 1 | Fair | 0 Participants |
| Intervention | PrEP Adherence | Month 1 | Good | 5 Participants |
| Intervention | PrEP Adherence | Month 1 | Very good | 4 Participants |
| Intervention | PrEP Adherence | Month 1 | Excellent | 2 Participants |
| Intervention | PrEP Adherence | Month 1 | Missing or not taking PrEP | 18 Participants |
| Intervention | PrEP Adherence | Month 3 | Poor | 1 Participants |
| Intervention | PrEP Adherence | Month 3 | Fair | 2 Participants |
| Intervention | PrEP Adherence | Month 3 | Good | 5 Participants |
| Intervention | PrEP Adherence | Month 3 | Very good | 2 Participants |
| Intervention | PrEP Adherence | Month 3 | Excellent | 2 Participants |
| Intervention | PrEP Adherence | Month 3 | Missing or not taking PrEP | 17 Participants |
| Intervention | PrEP Adherence | Month 6 | Poor | 0 Participants |
| Intervention | PrEP Adherence | Month 6 | Fair | 1 Participants |
| Intervention | PrEP Adherence | Month 6 | Good | 4 Participants |
| Intervention | PrEP Adherence | Month 6 | Very good | 0 Participants |
| Intervention | PrEP Adherence | Month 6 | Excellent | 2 Participants |
| Intervention | PrEP Adherence | Month 6 | Missing or not taking PrEP | 22 Participants |
| Standard Care | PrEP Adherence | Month 6 | Fair | 3 Participants |
| Standard Care | PrEP Adherence | Month 1 | Poor | 0 Participants |
| Standard Care | PrEP Adherence | Month 3 | Very good | 2 Participants |
| Standard Care | PrEP Adherence | Month 1 | Fair | 1 Participants |
| Standard Care | PrEP Adherence | Month 6 | Missing or not taking PrEP | 20 Participants |
| Standard Care | PrEP Adherence | Month 1 | Good | 7 Participants |
| Standard Care | PrEP Adherence | Month 3 | Excellent | 2 Participants |
| Standard Care | PrEP Adherence | Month 1 | Very good | 2 Participants |
| Standard Care | PrEP Adherence | Month 6 | Good | 3 Participants |
| Standard Care | PrEP Adherence | Month 1 | Excellent | 0 Participants |
| Standard Care | PrEP Adherence | Month 3 | Missing or not taking PrEP | 14 Participants |
| Standard Care | PrEP Adherence | Month 1 | Missing or not taking PrEP | 21 Participants |
| Standard Care | PrEP Adherence | Month 6 | Excellent | 2 Participants |
| Standard Care | PrEP Adherence | Month 3 | Poor | 0 Participants |
| Standard Care | PrEP Adherence | Month 6 | Poor | 0 Participants |
| Standard Care | PrEP Adherence | Month 3 | Fair | 7 Participants |
| Standard Care | PrEP Adherence | Month 6 | Very good | 3 Participants |
| Standard Care | PrEP Adherence | Month 3 | Good | 6 Participants |
Secondary
PrEP Drug Levels
Tenofovir levels measured in dried blood spots
Time frame: Month 3 and Month 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | PrEP Drug Levels | Month 6 | TFV-DP not detected | 22 Participants |
| Intervention | PrEP Drug Levels | Month 6 | Missing | 3 Participants |
| Intervention | PrEP Drug Levels | Month 3 | TFV-DP detected | 3 Participants |
| Intervention | PrEP Drug Levels | Month 3 | TFV-DP not detected | 23 Participants |
| Intervention | PrEP Drug Levels | Month 3 | Missing | 3 Participants |
| Intervention | PrEP Drug Levels | Month 6 | TFV-DP detected | 4 Participants |
| Standard Care | PrEP Drug Levels | Month 3 | Missing | 1 Participants |
| Standard Care | PrEP Drug Levels | Month 6 | TFV-DP not detected | 21 Participants |
| Standard Care | PrEP Drug Levels | Month 3 | TFV-DP not detected | 23 Participants |
| Standard Care | PrEP Drug Levels | Month 6 | Missing | 4 Participants |
| Standard Care | PrEP Drug Levels | Month 6 | TFV-DP detected | 6 Participants |
| Standard Care | PrEP Drug Levels | Month 3 | TFV-DP detected | 7 Participants |
Secondary
PrEP Uptake
Ongoing PrEP use (yes or no) assessed by ACASI
Time frame: Month 1, Month 3, and Month 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | PrEP Uptake | Month 1 | Did not use PrEP since last visit | 12 Participants |
| Intervention | PrEP Uptake | Month 3 | Missed visit or missing data | 1 Participants |
| Intervention | PrEP Uptake | Month 3 | Used PrEP since last visit | 17 Participants |
| Intervention | PrEP Uptake | Month 6 | Used PrEP since last visit | 11 Participants |
| Intervention | PrEP Uptake | Month 1 | Missed visit or missing data | 1 Participants |
| Intervention | PrEP Uptake | Month 6 | Did not use PrEP since last visit | 16 Participants |
| Intervention | PrEP Uptake | Month 3 | Did not use PrEP since last visit | 11 Participants |
| Intervention | PrEP Uptake | Month 6 | Missed visit or missing data | 2 Participants |
| Intervention | PrEP Uptake | Month 1 | Used PrEP since last visit | 16 Participants |
| Standard Care | PrEP Uptake | Month 6 | Missed visit or missing data | 4 Participants |
| Standard Care | PrEP Uptake | Month 1 | Used PrEP since last visit | 14 Participants |
| Standard Care | PrEP Uptake | Month 1 | Did not use PrEP since last visit | 15 Participants |
| Standard Care | PrEP Uptake | Month 1 | Missed visit or missing data | 2 Participants |
| Standard Care | PrEP Uptake | Month 3 | Used PrEP since last visit | 18 Participants |
| Standard Care | PrEP Uptake | Month 3 | Did not use PrEP since last visit | 12 Participants |
| Standard Care | PrEP Uptake | Month 3 | Missed visit or missing data | 1 Participants |
| Standard Care | PrEP Uptake | Month 6 | Used PrEP since last visit | 13 Participants |
| Standard Care | PrEP Uptake | Month 6 | Did not use PrEP since last visit | 14 Participants |