Clinical trial NCT05467306: Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
Official title: Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-20
Enrollment: 1900
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.

Detailed description: In Aim 1, the investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.

Pharmacy selection for cluster RCT (Aim 1): The investigators conducted a landscape analysis of all pharmacies in Kisumu, Kenya as part of the team's ongoing pharmacy-based PrEP delivery studies. In this analysis, the investigators gathered information on the types of customers who attend pharmacies, the types of services offered (e.g., HIV testing) and products purchased (e.g., contraceptive methods) at pharmacies, and availability of a separate private consultation room. The investigators will select 20 pharmacies based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms).

Randomization (Aim 1): All the pharmacies will receive standard pharmacy-based PrEP delivery and be randomized to either receive (n=10 pharmacies) or not receive (n=10 pharmacies) a nurse-navigator to assist with PrEP delivery. To ensure balance between randomization arms in terms of key site characteristics, sites will be categorized on AGYW volume (i.e., monthly number of purchases made by AGYW clients) and distribution frequency of contraceptive methods purchased (based on pharmacy log data) and restricted randomization will be used for site (cluster) allocation to intervention and control arms. Specifically, all possible randomizations that evenly distribute sites on these specified factors (AGYW client volume and distribution of contraceptive methods) into 2 study arms will be generated, and one combination will be selected using a random number generator. Randomization and allocation will be performed by a biostatistician from the UW CFAR Biometrics Core, who has no knowledge of sites other than the variables included in the restricted randomization process, and the Study Statistician, who received an MPH in Biostatistics from UW, will supervise the randomization process. Once assigned, the randomization allocation will be unblinded. Since the randomization will occur at the pharmacy level, it is impossible to blind study team members or participants to the randomization assignments. However, procedures to minimize the influence of the unblinded nature of this study on outcomes will be implemented. Ongoing data monitoring will not include information about study endpoints disaggregated by site or study arm. Only the study statistician will review data on study endpoints by study arm or facility.

Eligibility criteria: Inclusion Criteria:

* Female gender
* Seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
* Age between ≥14 and \<25 years old
* Willingness to receive PrEP screening per national guidelines including HIV testing
* Not currently taking PrEP
* Able and willing to provide informed consent for participation

Exclusion Criteria:

* Male gender
* Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site
* Age \<14 and \>24 years old
* Not willing to receive PrEP screening per national guidelines including HIV testing
* Currently taking PrEP
* Not able and/or willing to provide informed consent for participation

Primary outcomes:
measure: PrEP initiation
timeFrame: At enrollment
measure: PrEP persistence
timeFrame: at 10 months
measure: PrEP adherence
timeFrame: at 10 months
Secondary outcomes:
measure: PrEP method selection
timeFrame: At enrollment
measure: Predictors of non-adherence
timeFrame: at 10 months
measure: STI incidence
timeFrame: at 10 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of Washington
name: Jillian Pintye, PhD
role: PRINCIPAL_INVESTIGATOR
References: