Partners Scale-Up Project (PSUP)

Conditions

HIV/AIDS

Related papers

No related papers found yet.

Interventions

This is an implementation study that seeks to scale up delivery of PrEP through public facilities

Open label

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For HIV-1 uninfected members of the couple - Age =18 - Able and willing to provide consent for follow-up in the cohort - HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines - Not currently using PrEP For HIV-1 infected members of the couple - Age =18 - Able and willing to provide consent for follow-up in the cohort - HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including: o HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or o Trying to conceive For key delivery informants - Able and willing to provide consent

Exclusion criteria

Exclusion criteria: Contraindication for TDF/FTC

Design outcomes

Primary

Measure	Time frame
Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates.	—

Measure

Time frame

Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates.

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Secondary

Measure	Time frame
Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates.	—

Measure

Time frame

Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates.

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Countries

Kenya

Contacts

Public ContactElizabeth Irungu

Country Director PSUP

eirungu@pipsthika.org0721861147

Outcome results

None listed