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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Ministry of Health and Child Welfare, Zimbabwe | OTHER |
| University of Zimbabwe | OTHER |
| Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe |
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This study will assess the safety of the PrePex device as applied to HIV positive men by assessing the rate of clinical adverse events. The study will include adult, HIV + men who are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child Care (MOHCC) eligibility criteria.
According to mathematical modeling, Voluntary Medical Male Circumcision (VMMC) has the potential to have a major impact on reducing HIV incidence in areas with high HIV prevalence and low prevalence of male circumcision, as is the case in Zimbabwe. Male circumcision devices have the potential to accelerate VMMC scale-up as the procedure is faster and simpler and can be safely performed by nurses. However, fear of social stigma and desire to avoid HIV testing remain potential barriers to those HIV+ men who would otherwise seek out VMMC. Study subjects (n=400) are HIV+ males who elect to undergo VMMC with PrePex as a study subject, and healthcare workers involved in implementation of PrePex on HIV+ male subjects. The aim of the study is to determine if PrePex can be used safely among HIV+ men with similar rates of adverse events to HIV-uninfected men. If so, then the barrier of mandatory HIV testing as part of VMMC could be removed, encouraging more men to undergo the procedure. Determining PrePex safety in HIV+ men would also allow both those with unknown status and those with positive status to undergo MC with PrePex. Determining the barriers to performing VMMC among HIV+ men among healthcare workers, if any, would also inform future policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+ PrePex | Experimental | PrePex male circumcision device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrePex male circumcision device | Device | PrePex non-surgical male circumcision device applied to eligible, consenting HIV-infected men in Zimbabwe to determine the rate of adverse events as compared to non HIV-infected men. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events among HIV+ males using PrePex device | The primary safety endpoint is the incidence of clinical adverse events and device-related incidents.
Note: This list of AEs is not exhaustive. Severity of AE will be determined according to PEPFAR/OGAC guidelines | Device application through complete wound healing (up to 90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment at key time points |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Barnhart, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zengeza Clinic | Chitungwiza | Harare | Zimbabwe |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| UNKNOWN |
The study is a one arm, open label, prospective, cohort field study to assess the safety and acceptability of PrePex device circumcision device when performed by certified PrePex circumcision providers (physicians & nurses) in a HIV-infected male population.
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| Placement through complete healing (up to 90 days) |
| Abstinence until complete wound healing | Survival analysis of the timing of resumed sexual activity among subjects | Post placement through complete healing (up to 90 days) |
| Factors associated with abstinence until complete wound healing | Patient factors (knowledge, attitudes) associated with abstinence from sex until wound healing is complete | Post placement through complete healing (approximately 90 days for men who participate in the qualitative component) |
| Time to complete healing | Mean of days for complete healing (continuous measure) and factors associated with number of days to complete healing (continuous outcome - multiple linear regression)
| Device placement through complete healing (up to 90 days) |
| Cosmetic results |
| At complete healing (up to 90 days) |
| Patient satisfaction | A composite measure created among patients involved in the qualitative component who will be asked about satisfaction with the PrePex™ MC procedure, barriers and motivators to uptake of VMMC through PrePex™, opinions around convenience of the device, tolerance of potential odour and whether participants would recommend PrePex™ MC to others. | 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure |
| Patient daily life | Patients involved in the qualitative component will be asked about activities of daily living restrictions. They will complete a brief form that includes listing of activities of daily living, whether they are interrupted and for how long. This includes the average number of lost working hours (or potential working hours in unemployed). A composite measure will be created. | 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure |
| PrePex staff perceptions | Responses by clinicians to Likert scale questions on their beliefs about PrePex VMMC and using this procedure on HIV+ men | 4 weeks after study implementation begins |
| PrePex staff clinical skills | An overall assessment of clinician skills as a group will be made by combining and reporting on several indirect measures. Included measures will be the proportion of clients experiencing AEs and the average procedure time. • Assessing AE monitoring and reporting systems through
| At study closing,approximately 18 months after study initiation |
| PrePex AE monitoring and reporting systems | An ongoing assessment of AE monitoring and reporting systems through
| During all active follow-up: 90 days for participants |
| PrePex staff perceptions of their clinical skills | Compilation report of Likert scale results from questions ascertaining PrepPex training, abilities, productivity and confidence. | 4 weeks after study implementation begins |
| PrePex staff satisfaction | Compilation report on responses to likert scales question on their satisfaction performing PrePex on HIV+ men. | 4 weeks after study implementation begins |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |