HIV InfectionsINSIGHTNCT05746065
A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women
An observational study of HIV Infections, run by University of Washington at 20 sites in 7 countries.
Trial summary
INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance. There are no specific intervention arms or comparative treatment plans. Read more about this study
- Who is it for?
- Ages 16 to 31 years, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- PrEP
- How many people
- 3,087 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 31 years
- Women only
- Child, Adult
Study population: This project will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative women ages 16-30 in locations in eSwatini, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe to understand PrEP uptake, use, persistence and preferences for attributes of long-acting PrEP products and aspects of PrEP delivery for long-acting PrEP
Who may be able to join
- 16-30 years of age
- Female
Who cannot join
- not sexually active
- over 31 years of age at consent
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
South Africa14 sites
Madibeng Centre for Research
Brits, North West, 0250
University of Cape Town--Khayekutsha
Cape Town, Western Cape, 7784
UCT-Masi
Cape Town, Western Cape, 7975
SA Medical Research Councit, Chatsworth
Chatsworth, KwaZulu-Natal, 3370
Maternal Adolescent & Child Health Research (MatCH)
Durban, KwaZulu-Natal, 4001
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, 1864
Wits Reproductive Health & HIV Institute (WRHI)
Johannesburg, Gauteng, 2000
Helen Joseph Hospital--CHRU
Johannesburg, Gauteng, 2092
Aurum Institute Klerksdorp (CRS)
Klerksdorp, North West, 0299
Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, 3370
Emavundleni Research Center, DTHF
Nyanga, Western Cape, 7750
Human Sciences Research Council (HSRC)
Pretoria, Gauteng, 0001
Setshaba Research Center
Pretoria, Gauteng, 0152
Aurum Institute--Rustenburg
Rustenburg, North West, 2671
About this study
Official title: A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women
INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance.
There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.
Read the detailed description
Primary goals:
- Estimate HIV incidence using recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.
- Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP.
- Evaluate young women's preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment.
- Assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.
- Conditions
- HIV Infections
- Being tested
- PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
Also called Truvada
Eligible women will be prescribed PrEP intake in accordance to standard of care should they choose. We are interested in observing adherence, barriers to adherence, and other factors that effect sexual health.
What is being measured
The primary outcome is the main question the study is designed to answer.
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
We will collect data on STI prevalence, contraception use, sexual behavior, risk perception as correlates for PrEP uptake, persistence and adherence. Adherence will be measured by the timing of PrEP refills, self-reported PrEP use, and drug level testing for tenofovir (TFV) levels .PrEP adherence will be assessed during periods of risk, based on behavioral data and self-perceived risk. Participants in this cohort will be informed of other HIV prevention efficacy trials. A discrete choice experiment will be used to assess women's preferences around PrEP delivery form (pill and injection), dosing frequency, and relative dose forgiveness for different PrEP formulations. A patient-facing decision support tool about PrEP options will be evaluated with respect to its utility in assisting young women to consider their HIV prevention needs and PrEP preferences.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie Celum, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746065
- Sponsor's protocol ID
- STUDY00015634
- Acronym
- INSIGHT
- Status last verified
- May 2024
- First submitted
- 5 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mukui I, Peacock S, Donnell D, Gati-Mirembe B, Krows M, Bukusi EA, Imaan L, Kotze P, Gill KM, Macdonald P, Louw C, Jaggernath M, Marais A, Peters RPH, Delany-Moretlwe S, Ward A, du Preez P, Kasaro M, Gandhi M, Heffron R, Celum C; INSIGHT Study Team. High prevalence and incidence of curable sexually transmitted infections among young women using oral HIV pre-exposure prophylaxis in sub-Saharan Africa: results from the INSIGHT Cohort study. Sex Transm Infect. 2025 Dec 25:sextrans-2025-056625. doi: 10.1136/sextrans-2025-056625. Online ahead of print.
PubMed 41448908Gati Mirembe B, Donnell D, Krows M, Zwane Z, Bukusi E, Panchia R, Louw C, Mwelase N, Selepe P, Senne M, Naidoo L, Chihana R, Kasaro M, Nuwagaba-Biribonwoha H, Kotze P, Gill K, MacDonald P, vanHeerden A, Bosman S, Jaggernath M, du Preez P, Ward A, Peters RPH, Delany-Moretlwe S, Peacock S, Johnson R, Caucutt J, Morrison S, Wang G, Gandhi M, Velloza J, Heffron R, Celum C; INSIGHT Study Team. High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort. J Int AIDS Soc. 2024 Dec;27(12):e26389. doi: 10.1002/jia2.26389.
PubMed 39653676
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women
- ClinicalTrials.gov ID
- NCT05746065
- Acronym / sponsor ID
- INSIGHT / STUDY00015634
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 27 Feb 2023 (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.
INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance.
There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.
Detailed description
Primary goals:
- Estimate HIV incidence using recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.
- Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP.
- Evaluate young women's preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment.
- Assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 31 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- This project will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative women ages 16-30 in locations in eSwatini, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe to understand PrEP uptake, use, persistence and preferences for attributes of long-acting PrEP products and aspects of PrEP delivery for long-acting PrEP
Key inclusion criteria (2 listed)
- 16-30 years of age
- Female
Key exclusion criteria (2 listed)
- not sexually active
- over 31 years of age at consent
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 |
|---|---|---|
| PrEPAlso: TruvadaEligible women will be prescribed PrEP intake in accordance to standard of care should they choose. We are interested in observing adherence, barriers to adherence, and other factors that effect sexual health. | Drug | – |
Primary outcome
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
Time frame: 1 year
We will collect data on STI prevalence, contraception use, sexual behavior, risk perception as correlates for PrEP uptake, persistence and adherence. Adherence will be measured by the timing of PrEP refills, self-reported PrEP use, and drug level testing for tenofovir (TFV) levels .PrEP adherence will be assessed during periods of risk, based on behavioral data and self-perceived risk. Participants in this cohort will be informed of other HIV prevention efficacy trials. A discrete choice experiment will be used to assess women's preferences around PrEP delivery form (pill and injection), dosing frequency, and relative dose forgiveness for different PrEP formulations. A patient-facing decision support tool about PrEP options will be evaluated with respect to its utility in assisting young women to consider their HIV prevention needs and PrEP preferences.
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 8 May 2024.
- Derived from this study: PubMed 41448908Mukui I, Peacock S, Donnell D, Gati-Mirembe B, Krows M, Bukusi EA, Imaan L, Kotze P, Gill KM, Macdonald P, Louw C, Jaggernath M, Marais A, Peters RPH, Delany-Moretlwe S, Ward A, du Preez P, Kasaro M, Gandhi M, Heffron R, Celum C; INSIGHT Study Team. High prevalence and incidence of curable sexually transmitted infections among young women using oral HIV pre-exposure prophylaxis in sub-Saharan Africa: results from the INSIGHT Cohort study. Sex Transm Infect. 2025 Dec 25:sextrans-2025-056625. doi: 10.1136/sextrans-2025-056625. Online ahead of print.
- Derived from this study: PubMed 39653676Gati Mirembe B, Donnell D, Krows M, Zwane Z, Bukusi E, Panchia R, Louw C, Mwelase N, Selepe P, Senne M, Naidoo L, Chihana R, Kasaro M, Nuwagaba-Biribonwoha H, Kotze P, Gill K, MacDonald P, vanHeerden A, Bosman S, Jaggernath M, du Preez P, Ward A, Peters RPH, Delany-Moretlwe S, Peacock S, Johnson R, Caucutt J, Morrison S, Wang G, Gandhi M, Velloza J, Heffron R, Celum C; INSIGHT Study Team. High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort. J Int AIDS Soc. 2024 Dec;27(12):e26389. doi: 10.1002/jia2.26389.
- Individual participant dataSharing planned: No
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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 Celum, MD principal investigator
University of Washington
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of Washington at 20 sites in 7 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 2 inclusion and 2 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda and 2 more countries. 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?
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women (time frame: 1 year). 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 NCT05746065, which also lists 2 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 8 May 2024.