HIV/AIDSNCT03490058
The Prevention Options for Women Evaluation Research (POWER) Cohort
An observational study of HIV/AIDS, run by University of Washington at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Truvada
- Type of treatment
- Pill or oral medicine
- How many people
- 2,255 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Jun 2017to 23 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.
Who may be able to join
- Age 16-25 (16 and 17 year olds, where permissible by national regulations and local IRB approval)
- Able and willing to provide written informed consent
- Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months)
- HIV uninfected based on negative HIV rapid tests, on the date of enrollment
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
Desmond Tutu HIV Foundation
Cape Town
Wits Reproductive Health and HIV Institute
Johannesburg
About this study
Official title: A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort
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.
Read the detailed description
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.
- Conditions
- HIV/AIDS
- Being tested
- Truvada
- Keywords
- pre-exposure prophylaxis, young women, delivery of health care, HIV infections/prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
| Study group | Role | What they receive |
|---|---|---|
| Young women | Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada. Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Secondary outcomes (3)
PrEP initiation
Measure the number of young women who initiate PrEP.
Measured: 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.
Measured: Up to 36 months
HIV seroconversion
Assess HIV incidence during PrEP use and non-use.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start14 Jun 2017
- Primary completion4 Dec 2020
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, Wits Reproductive Health and HIV Institute, Kenya Medical Research Institute, United States Agency for International Development (USAID), RTI International, Harvard Medical School (HMS and HSDM), University of Pittsburgh, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie L Celum, MD, MPH, Principal investigator, University of WashingtonJared M Baeten, MD, PhD, Principal investigator, University of WashingtonRachel Johnson, MPH, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490058
- Sponsor's protocol ID
- STUDY00000950
- Other IDs
- R01MH114544, AID-OAA-A-15-00034
- Status last verified
- Dec 2021
- First submitted
- 19 Mar 2018
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.
Publications
Katz AWK, Roberts S, Rousseau E, Khoza MN, Mogaka F, Bukusi E, Delany-Moretlwe S, Bekker LG, Morton JF, Johnson R, Baeten JM, Celum C, van der Straten A. Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa. J Assoc Nurses AIDS Care. 2023 Jan-Feb 01;34(1):45-57. doi: 10.1097/JNC.0000000000000363. Epub 2022 Sep 23.
PubMed 36170124Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962.
PubMed 35822945Roche SD, Barnabee G, Omollo V, Mogaka F, Odoyo J, Bukusi EA, Morton JF, Johnson R, Celum C, Baeten JM, O'Malley G. Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study. BMC Health Serv Res. 2022 Mar 30;22(1):422. doi: 10.1186/s12913-022-07742-8.
PubMed 35354456Omollo V, Bukusi EA, Kidoguchi L, Mogaka F, Odoyo JB, Celum C, Morton J, Johnson R, Baeten JM. A Pilot Evaluation of Expedited Partner Treatment and Partner Human Immunodeficiency Virus Self-Testing Among Adolescent Girls and Young Women Diagnosed With Chlamydia trachomatis and Neisseria gonorrhoeae in Kisumu, Kenya. Sex Transm Dis. 2021 Oct 1;48(10):766-772. doi: 10.1097/OLQ.0000000000001430.
PubMed 33859147
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort
- ClinicalTrials.gov ID
- NCT03490058
- Acronym / sponsor ID
- STUDY00000950
- Conditions
- HIV/AIDS
- Keywords
- pre-exposure prophylaxis, young women, delivery of health care, HIV infections/prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,255 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, Wits Reproductive Health and HIV Institute, Kenya Medical Research Institute, United States Agency for International Development (USAID), RTI International, Harvard Medical School (HMS and HSDM), University of Pittsburgh, National Institute of Mental Health (NIMH)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young women | – | Drug: TruvadaSexually active HIV-uninfected women between 16-25 years of age will be given Truvada. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.
Key inclusion criteria (4 listed)
- Age 16-25 (16 and 17 year olds, where permissible by national regulations and local IRB approval)
- Able and willing to provide written informed consent
- Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months)
- HIV uninfected based on negative HIV rapid tests, on the date of enrollment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruvadaA fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP. | Drug | Young women |
Primary outcome
Demonstrate PrEP delivery models for young women in different settings and geographies.
Time frame: Up to 36 months
Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.
3 secondary outcomes
PrEP initiation
Time frame: Up to 36 months
PrEP adherence
Time frame: Up to 36 months
HIV seroconversion
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 36170124Katz AWK, Roberts S, Rousseau E, Khoza MN, Mogaka F, Bukusi E, Delany-Moretlwe S, Bekker LG, Morton JF, Johnson R, Baeten JM, Celum C, van der Straten A. Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa. J Assoc Nurses AIDS Care. 2023 Jan-Feb 01;34(1):45-57. doi: 10.1097/JNC.0000000000000363. Epub 2022 Sep 23.
- Derived from this study: PubMed 35822945Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962.
- Derived from this study: PubMed 35354456Roche SD, Barnabee G, Omollo V, Mogaka F, Odoyo J, Bukusi EA, Morton JF, Johnson R, Celum C, Baeten JM, O'Malley G. Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study. BMC Health Serv Res. 2022 Mar 30;22(1):422. doi: 10.1186/s12913-022-07742-8.
- Derived from this study: PubMed 33859147Omollo V, Bukusi EA, Kidoguchi L, Mogaka F, Odoyo JB, Celum C, Morton J, Johnson R, Baeten JM. A Pilot Evaluation of Expedited Partner Treatment and Partner Human Immunodeficiency Virus Self-Testing Among Adolescent Girls and Young Women Diagnosed With Chlamydia trachomatis and Neisseria gonorrhoeae in Kisumu, Kenya. Sex Transm Dis. 2021 Oct 1;48(10):766-772. doi: 10.1097/OLQ.0000000000001430.
- Individual participant dataSharing planned: Yes. Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie L Celum, MD, MPH principal investigator
University of Washington
Jared M Baeten, MD, PhD principal investigator
University of Washington
Rachel Johnson, MPH study director
University of Washington
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by University of Washington at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate PrEP delivery models for young women in different settings and geographies. (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490058, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.