An observational study in HIV/AIDS, sponsored by University of Washington. Completed at 3 sites in 2 countries. Open to female participants aged 16 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by University of Washington · Observational
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Among 38 studies in Acquired Immunodeficiency Syndrome by University of Washington — 7 open to participants now, 10 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · University of Washington.
Among the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington, this one is one of 2 that started in 2017, is one of 3 observational ones, and was the 16th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington are open now, in 2 countries. Recruiting first, the newest first:
University of Washington · Sites in Uganda
Ages 15+ · Healthy volunteers
University of Washington · Sites in Kenya
Ages 15+ · Healthy volunteers
University of Washington · Sites in Kenya
Ages 18–50 · Women only
University of Washington · Sites in Kenya
Women only · Healthy volunteers
University of Washington · Sites in Kenya
Healthy volunteers
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 16 Years to 25 Years · female · healthy volunteers too.
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38 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,255 is above the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 360 across the 35 interventional studies, 850 across the 3 observational. Of the 27 that completed or were terminated, 14 (52%) have results posted.
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University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
1 of the studies in Acquired Immunodeficiency Syndrome by University of Washington that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05467306University of WashingtonEnhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform | 2027-03-31 |
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Among the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
PrEP will be delivered to young women according to emerging national guidelines in family planning clinics (Kisumu, Kenya), youth friendly clinics (Johannesburg, South Africa), and mobile youth friendly clinics (Cape Town, South Africa). The investigators will evaluate PrEP delivery and follow cohorts of young women at each clinic location to understand PrEP uptake and use. In the Kisumu clinics, the investigators will also offer expedited partner therapy and partner HIV self-tests to women who test positive for chlamydia and/or gonorrhea. At one clinic in Johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate PrEP.
Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.
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.
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.
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.
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.
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.
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
Drug: Truvada
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
Demonstrate PrEP delivery models for young women in different settings and geographies.
Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.
Time frame: Up to 36 months
PrEP initiation
Measure the number of young women who initiate PrEP.
Time frame: Up to 36 months
PrEP adherence
Adherence by young women to PrEP. Adherence will be measured by the timing of PrEP refills and self-reported PrEP use. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV and a subset who remain HIV uninfected.
Time frame: Up to 36 months
HIV seroconversion
Assess HIV incidence during PrEP use and non-use.
Time frame: Up to 36 months
Assess cost and cost-effectiveness of PrEP when delivered in public health clinics.
Time-motion studies will be conducted to define the cost and cost effectiveness of the intervention in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness of PrEP over routine HIV care.
Time frame: Up to 36 months
Evaluate the acceptability of delivering expedited partner therapy.
Measure the number of women who accept STI expedited partner therapy and HIV self-test kits for their partners.
Time frame: Up to 36 months
Assess the effect of a decision support tool on PrEP uptake
Using a randomized design, evaluate if a decision support tool increases PrEP uptake.
Time frame: Up to 36 months
Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP
Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery.
Time frame: Up to 12 months
Plan to share: Yes — Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.
Ran from Jun 2017 to primary completion in Dec 2020, 41 months.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 41 months is below that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →