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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068619 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).
HPTN 075 is an observational cohort study. Participants will be accrued over six months at four sites in SSA using convenience sampling strategies, with no replacement for participants lost to follow-up. Each participant will be followed for 12 months, during which five study visits involving structured HIV behavioral assessments, medical examinations, and collection of biological samples will be conducted (including enrollment and quarterly follow-up visits). Participants who do not complete 12 months of follow-up will be contacted to explore reasons for no longer participating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Observational study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | HPTN 075 is an observational study in sub-Saharan MSM |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of approximately 400 participants | all 4 sites must collectively recruit 400 participants | July 2015-July 2016 |
| Retention of approximately 400 participants | at least 90% of participants must be retained | July 2015-July 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV incidence | Measured by HIV RNA from plasma samples | July 2015-July 2017 |
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Inclusion Criteria:
Men who are already on PrEP will not be excluded. Additionally, self- or other-identified transgender women and male sex workers will not be excluded. There will, however, be no specific effort to recruit these groups.
Exclusion Criteria:
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Men, regardless of HIV infection status, aged 18-44 years living in SSA who report anal sex with a man in the past 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Theodorus Sandfort, PhD | Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kisumu | Kisumu | 40100 | Kenya | |||
| Johns Hopkins Project |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 15, 2016 | Mar 14, 2022 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Plasma samples will be stored from each study visit
| Blantyre |
| Chichiri |
| Malawi |
| Groote Schuur | Observatory | Cape Town | 7925 | South Africa |
| PHRU | Soweto | Gauteng | 2193 | South Africa |