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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019178 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Peer Navigation) | Experimental | Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator |
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| Control Group | Placebo Comparator | Participants randomized to this group will receive a single group session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Navigation Group | Behavioral | Participants randomized to the intervention will receive behavioral lifestyle education on topics related to biomedical HIV prevention. This will include 4 group sessions and 4 one-on-one sessions with a peer navigator. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP initiation | Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription. | Post baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP adherence | Biological assess of tenofovir (TFV) levels in client's urine | 2-months post-randomization, 4-months post-randomization, and 6-months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender Black women (Black women who were born with female genital and also identify as women)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiara C. Willie, PhD, MA | Contact | 410-614-2686 | twillie2@jhu.edu | |
| Project Director, DrPH | Contact | jmassie4@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tiara C. Willie, PhD, MA | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Recruiting | Baltimore | Maryland | 21205 | United States |
Individual participant data will not be shared due to privacy, confidentiality, and ethical considerations. Protecting personal information is essential to comply with privacy laws (e.g., HIPAA) and the terms of informed consent. Sharing such data could breach confidentiality agreements and potentially expose sensitive information, even if anonymized. Additionally, there are concerns about data security, misuse, and the potential harm to participants, which researchers must carefully consider.
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