A Phase 4 interventional study of Multiple Product PrEP Program and Routine Oral PrEP in Hiv, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in Kenya. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Prevention
Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria for Adolescent Girls and Young Women seeking reproductive health services:
Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).
AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.
Willing and able to partake in an process. Able to speak and read in Kiswahili or English.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the active comparator, clinics will offer the standard of care PrEP Program, which includes daily oral PrEP for young women.
Drug: Routine Oral PrEP
In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.
Drug: Multiple Product PrEP Program · Drug: Routine Oral PrEP
In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.
Daily oral PrEP
PrEP initiation
Women who start to use PrEP
Time frame: From enrolment to 6 months
PrEP persistence at 3 months
Women who continue to use PrEP 3 months since they initiated PrEP
Time frame: From enrolment to 3 months
PrEP persistence at 6 months
Women who continue to use PrEP 6 months since they initiated PrEP
Time frame: Enrolment to 6 months
Plan to share: Undecided
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Acquired Immunodeficiency Syndrome →
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