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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH114523 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| MRC/UVRI and LSHTM Uganda Research Unit | OTHER |
| Medical Research Council | OTHER_GOV |
| London School of Hygiene and Tropical Medicine | OTHER |
| National Institute of Mental Health (NIMH) |
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The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP |
|
| comparison | Active Comparator | participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POPPi | Behavioral | behavioral intervention with offer of HIV self test |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of PrEP | Initiation of PrEP using the pharmacy records indicating PrEP received by participants. | 6 months |
| Adherence to PrEP | Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel King, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uganda Virus Research Institute | Entebbe | Uganda |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP POPPi behavioral intervention: behavioral intervention with offer of HIV self test |
| FG001 | Comparison |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 12, 2019 |
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| NIH |
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| Comparison |
| Behavioral |
standard of care |
|
participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | participants received a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP POPPi behavioral intervention: behavioral intervention with offer of HIV self test |
| BG001 | Comparison | participants were not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention |
| BG002 | 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 | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Initiation of PrEP | Initiation of PrEP using the pharmacy records indicating PrEP received by participants. | Number of participants who initiated PrEP using pharmacy pill count records. | Posted | Count of Participants | Participants | 6 months |
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| |||||||||||||||||||||||||||||
| Primary | Adherence to PrEP | Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported. | This is the number of participants who took PrEP and had samples tested at endline (12 months) | Posted | Count of Participants | Participants | 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | behavioral intervention | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Comparison | standard of care | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rachel King | University of California San Francisco | +256785304516 | rachel.king@ucsf.edu |
| Mar 13, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| >=65 years |
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| Male |
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