HIV/AIDS, Sexually Transmitted Diseases
Conditions
Keywords
Black MSM, Social network
Brief summary
The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men \[referred to as Index\] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.
Detailed description
Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious co-infections that affect HIV clinical outcomes, and remain a risk for individuals using PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is a potential approach through which to improve HIV and STI testing rates in MSM. Internet-based distribution (herein: web-based) of STI self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. Web-based self-HIV oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. Despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. In the proposed study, investigators will pilot test an intervention that address these barriers by training BMSM with information about the accuracy of the HIV rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV and STI treatment and PrEP services. Study participants will utilize a secure website to request test kits.
Interventions
BEHAVIORALPeer Mentor
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
BEHAVIORALWebsite only
Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
17 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* self-report male sex * condomless anal sex with \>1 male in the prior 6 months * self-report Black race * aged 18 or older * internet use at least once a week.
Exclusion criteria
* younger than 17
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Session Attendance | 3 month | number of participants who completed 80% |
| Number of Index Participants Who Requested Test Kits | 3 months | Number of Index participants who requested test kits is reported |
| Number of Participants Who Return Kits for Testing | 3 month | Number of participants who returned kits to lab for testing is reported. |
Countries
United States
Participant flow
Pre-assignment details
163 participants were consented. 64 participants assigned to Peer Mentor condition (Index and network); 55 participants assigned to the control (Index and network); 44 participants were withdrawn pre-assignment and not assigned to a condition.
Participants by arm
| Arm | Count |
|---|---|
| Peer Mentor Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes. | 64 |
| Control Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing. | 55 |
| Not Assigned Participants not randomized to either condition | 44 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 42 | 39 |
Baseline characteristics
| Characteristic | Peer Mentor | Control | Not Assigned | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 55 Participants | 44 Participants | 163 Participants |
| Age, Continuous | 38.0 year STANDARD_DEVIATION 10.6 | 38.5 year STANDARD_DEVIATION 9.2 | 35.25 year STANDARD_DEVIATION 3.7 | 38.2 year STANDARD_DEVIATION 9.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 52 Participants | 42 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants | 53 Participants | 2 Participants | 112 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 41 Participants | 44 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 62 Participants | 54 Participants | 44 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 55 |
| other Total, other adverse events | 0 / 64 | 0 / 55 |
| serious Total, serious adverse events | 0 / 64 | 0 / 55 |
Outcome results
Primary
Number of Index Participants Who Requested Test Kits
Number of Index participants who requested test kits is reported
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer Mentor | Number of Index Participants Who Requested Test Kits | 9 Participants |
| Control | Number of Index Participants Who Requested Test Kits | 17 Participants |
Primary
Number of Participants Who Return Kits for Testing
Number of participants who returned kits to lab for testing is reported.
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer Mentor | Number of Participants Who Return Kits for Testing | 4 Participants |
| Control | Number of Participants Who Return Kits for Testing | 3 Participants |
Primary
Session Attendance
number of participants who completed 80%
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer Mentor | Session Attendance | 64 Participants |
| Control | Session Attendance | 55 Participants |