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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH095507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| United States Agency for International Development (USAID) | FED |
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The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.
An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP as a bridge to ART | Other | FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTC-TDF PrEP | Drug | FTC-TDF PrEP for HIV-1 uninfected partners |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio. | High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples. | 24 months |
| Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort. | High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort. | 24 months |
| Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort. | High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted. | 24 months |
| User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method. | Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both. | 24 months |
| User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods. |
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Inclusion Criteria:
For couples
For HIV-1 uninfected members of the couple (partner participants)
For HIV-1 infected members of the couple (index participants)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared M Baeten, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemri-Ucsf | Kisumu | Kenya | ||||
| Partners in Prevention-Thika |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30657642 | Derived | Nakku-Joloba E, Pisarski EE, Wyatt MA, Muwonge TR, Asiimwe S, Celum CL, Baeten JM, Katabira ET, Ware NC. Beyond HIV prevention: everyday life priorities and demand for PrEP among Ugandan HIV serodiscordant couples. J Int AIDS Soc. 2019 Jan;22(1):e25225. doi: 10.1002/jia2.25225. |
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Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ART |
| Drug |
ART for HIV-1 infected partners |
|
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods |
| 24 months |
| PrEP initiation by HIV uninfected partners. | Measure the number of HIV-1 uninfected partners initiating PrEP. Proportion of samples with detectable and quantifiable PrEP levels | 24 months |
| PrEP adherence: Self-reported missed doses of PrEP. | Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP. | 24 months |
| PrEP adherence: Detectable and quantifiable PrEP levels in plasma. | Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels. | 24 months |
| PrEP adherence: PrEP hold. | Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue. | 24 months |
| ART initiation. | Measure the number of HIV-1 infected partners initiating ART. | 24 months |
| ART Adherence. | Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency. | Proportion of visits when participants report having sex. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency. | Proportion of visits when participants report having condomless sex. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners. | Proportion of visits when HIV-1 uninfected partners report outside partners. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner. | Proportion of couples in which the HIV-1 uninfected partner is female. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions. | Proportion of couples with desire to conceive a child. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution. | Number of couples continuing their relationship during follow up. | 24 months |
| Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use. | Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner. | Proportion of HIV-1 infected partners initiating ART. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: Number of children. | Proportion of partnership reporting to have children at baseline. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count. | Proportion of HIV infected partners with CD4 count >200, >350, >500. | 24 months |
| Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner. | Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4. | 24 months |
| Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART. | We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation. | 24 months |
| PrEP use and pregnancy: HIV-1 infection. | Number of HIV-1 infections among women who continue PrEP in pregnancy. | 24 months |
| PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP. | Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie. | 24 months |
| PrEP use and pregnancy: Any serious adverse event. | Number of women who continue PrEP in pregnancy with any serious adverse event. | 24 months |
| Infant growth for women who continue PrEP in pregnancy: Length. | Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month. | 24 months |
| Infant growth for women who continue PrEP in pregnancy: Weight. | The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month. | 24 months |
| Infant growth for women who continue PrEP in pregnancy: Head circumference. | The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month. | 24 months |
| Thika |
| Kenya |
| Kabwohe Clinical Research Center | Bushenyi | Uganda |
| Partners in Prevention-Infectious Diseases Institute LTD | Kampala | Uganda |
| 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 |