Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
Not provided
Not provided
Not provided
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.
Primary goals:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Female participants
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Connie Celum, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICAP, eSwatini Prevention Center | Mbabane | Hhohho Region | H100 | Eswatini | ||
| Kenya Medical Research Institute (KEMRI) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41448908 | Derived | 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. | |
| 39653676 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood and urine collection to test for syphilis, trichomonas, gonorrhea, chlamydia and HIV.
| Nairobi |
| 00200 |
| Kenya |
| Queen Elizabeth Central Hospital | Blantyre | 312200 | Malawi |
| Perinatal HIV Research Unit (PHRU) | Johannesburg | Gauteng | 1864 | South Africa |
| Wits Reproductive Health & HIV Institute (WRHI) | Johannesburg | Gauteng | 2000 | South Africa |
| Helen Joseph Hospital--CHRU | Johannesburg | Gauteng | 2092 | South Africa |
| Human Sciences Research Council (HSRC) | Pretoria | Gauteng | 0001 | South Africa |
| Setshaba Research Center | Pretoria | Gauteng | 0152 | South Africa |
| SA Medical Research Councit, Chatsworth | Chatsworth | KwaZulu-Natal | 3370 | South Africa |
| Maternal Adolescent & Child Health Research (MatCH) | Durban | KwaZulu-Natal | 4001 | South Africa |
| Qhakaza Mbokodo Research Clinic | Ladysmith | KwaZulu-Natal | 3370 | South Africa |
| Madibeng Centre for Research | Brits | North West | 0250 | South Africa |
| Aurum Institute Klerksdorp (CRS) | Klerksdorp | North West | 0299 | South Africa |
| Aurum Institute--Rustenburg | Rustenburg | North West | 2671 | South Africa |
| University of Cape Town--Khayekutsha | Cape Town | Western Cape | 7784 | South Africa |
| UCT-Masi | Cape Town | Western Cape | 7975 | South Africa |
| Emavundleni Research Center, DTHF | Nyanga | Western Cape | 7750 | South Africa |
| Makerere University | Kampala | 10216 | Uganda |
| Kamwala Health Centre | Lusaka | Lusake | 00000 | Zambia |
| University of Zimbabwe | Harare | 7784 | Zimbabwe |
| Derived |
| Gati 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided