Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB00009216 | Other Identifier | JHSPH IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Mentor | Experimental | 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. |
|
| Control | Active Comparator | Is one individual-based session which will be conducted by sending a video about the website of a health educator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Mentor | Behavioral | Participants will be trained to be Peer Mentors and promote home-based testing to their social network |
|
| Measure | Description | Time Frame |
|---|---|---|
| Session Attendance | number of participants who completed 80% | 3 month |
| Number of Index Participants Who Requested Test Kits | Number of Index participants who requested test kits is reported | 3 months |
| Number of Participants Who Return Kits for Testing | Number of participants who returned kits to lab for testing is reported. | 3 month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Biologic male who identifies as male
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karin E Tobin, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lighthouse Studies @ Peer Point | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35798989 | Background | Tobin KE, Heidari O, Winiker A, Pollock S, Rothwell MD, Alexander K, Owczarzak J, Latkin C. Peer Approaches to Improve HIV Care Cascade Outcomes: a Scoping Review Focused on Peer Behavioral Mechanisms. Curr HIV/AIDS Rep. 2022 Aug;19(4):251-264. doi: 10.1007/s11904-022-00611-3. Epub 2022 Jul 7. |
Not provided
Not provided
Investigators will share data in a way that will protect participant confidentiality. Within 12 months of publication of the primary papers for this study, a dataset of aggregate values will be made available. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified; this will reduce the risk of small numbers resulting in deductive identification.
12 months after data collection is over
To Be Determined
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 Sexually Transmitted Infection (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Website only | Behavioral | 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. |
|
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were consented
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Not Assigned | Participants not randomized to either condition |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Session Attendance | number of participants who completed 80% | Posted | Count of Participants | Participants | 3 month |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Index Participants Who Requested Test Kits | Number of Index participants who requested test kits is reported | Posted | Count of Participants | Participants | 3 months |
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Return Kits for Testing | Number of participants who returned kits to lab for testing is reported. | Posted | Count of Participants | Participants | 3 month |
|
|
3 months
Participants who were not assigned to a condition were not assessed for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Peer Mentor: Participants will be trained to be Peer Mentors and promote home-based testing to their social network | 0 | 64 | 0 | 64 | 0 | 64 |
| EG001 | Control | Is one individual-based session which will be conducted by sending a video about the website of a health educator. 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. | 0 | 55 | 0 | 55 | 0 | 55 |
Not provided
Not provided
This study occurred during the COVID-19 pandemic and amid the stay at home orders. Therefore recruitment was interrupted and the delivery of the intervention and control were remote. The stay-at home orders also disrupted the follow-up activities.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karin Tobin | Johns Hopkins Bloomberg School of Public Health | 4105025368 | ktobin2@jhu.edu |
| Mar 25, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|