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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH134685 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Institute, Uganda | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based HIV self-testing and PrEP initiation | Experimental | Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation |
|
| Modified standard of care | No Intervention | Referral to health facility for HIV testing and PrEP initiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based HIV self-testing | Other | Integration of HIV self-testing into TB household contact investigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| PrEP uptake | Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit | From enrollment to the one-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP continuation | Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits | From enrollment to six-month follow-up visit |
| HIV testing coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer M Ross, MD, MPH | Contact | 206 543-9192 | jross3@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Ross, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Institute | Recruiting | Kampala | Uganda |
Select IPD will be available through the NIMH data archive
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Data will be shared through the NIMH Data Archive
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Household randomized implementation study
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| Home-based initiation of PrEP | Other | Integration of PrEP initiation into TB household contact investigation |
|
Proportion of participants known to be living with HIV or have tested HIV-negative among all participants
| From enrollment to six-month follow-up visit |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| 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 |