An interventional study of Pharmacy-based PrEP refill and gift voucher and Control (Standard of care) in Adherence, Medication and HIV Prevention, sponsored by University of California, Berkeley. Recruiting at 1 site in Zimbabwe. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Health services research
Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who have, in addition to the standard practice of refill pickups at CESHHAR clinics, the opportunity to retrieve PrEP refills at private pharmacies, and who receive gift card incentives at the designated refill time-points of 1, 3, and 6 months.
Behavioral: Pharmacy-based PrEP refill and gift voucher
Participants who do not have the opportunity to retrieve PrEP refills at private pharmacies. PrEP refill pick-ups are available through CESHHAR Zimbabwe's existing network of clinical sites.
Behavioral: Control (Standard of care)
The intervention arm of this study introduces the opportunity for a pharmacy-based PrEP refill system for sex workers, coupled with financial incentives to increase adherence. Participants receive PrEP medications from selected pharmacies, a strategy designed to improve PrEP access and enhance privacy/discretion. Additionally, participants in the intervention are awarded escalating gift card values for each successful refill collection at study pharmacies, aiming to incentivize continued PrEP use for effective HIV prevention. The intervention seeks to enhance convenience and motivate adherence through financial rewards.
For sex workers in the control group, PrEP refill pick-up will be available through CESHHAR's existing network of clinical sites. There is no gift card incentive and no pick-up at private pharmacies.
PrEP retention at 6 months
This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 1 will also be measured as follows: Proportion of visits completed as scheduled, by arm.
Time frame: 6 months
PrEP retention at 6 months among FSW who are 18-24 years of age
: PrEP retention at 6 months among FSW who are 18-24 years of age, stratified by pickup location. This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 2 will also be measured as follows: Proportion of visits completed as scheduled, by arm.
Time frame: 6 months
: PrEP retention at 6 months among participants who have remained active in sex work
PrEP retention at 6 months among participants who have remained active in sex work (based on program, referral app and microplanner data). This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 3 will also be measured as follows: Proportion of visits completed as scheduled, by arm.
Time frame: 6 months
FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies
FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies, defined as the proportion of PrEP refill pick-ups in intervention suburbs occurring at pharmacies.
Time frame: 9 months
HIV tests
The number and outcomes of HIV tests at the time of refill.
Time frame: 9 months
HIV care referrals
This outcome will measure the number of referrals for HIV care.
Time frame: 9 months
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 11 months after the start.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 11 months is below that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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