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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH136842-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Usual care) | No Intervention | The control period (usual care) will be when the clinics are still implementing the usual care model, prior to implementing the intervention. Prior to launching the intervention, all facilities will have a baseline phase of 3 months. That time, in conjunction with other periods when the clinics are implementing usual care will serve as the control period. | |
| HTS counselor-led PrEP care model | Experimental | During the intervention period, all core components of PrEP delivery - including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills will be conducted by existing facility HTS counselor as part of standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTS counselor-led PrEP care model | Other | PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP screening | Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points | Up to 42 months |
| PrEP initiation | Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools. | Up to 42 months |
| PrEP continuation | Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records. | Up to 42 months |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clare Brown, PhD | Contact | 206-543-8225 | brownce@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Mugwanya, MBChB, MS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenyatta National Hospital | Recruiting | Kisumu | Kenya |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Stepped-wedge cluster randomized trial of 20 public health clinics implementing the intervention of HTS counselor-led PrEP care
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| 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 |