Last reviewed · How we verify
NCT04778514: 952
A Crossover Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention
NA trial testing Dual Prevention Pill in HIV Infections in 30 participants. Completed in 11 September 2023.
11 September 2023
Quick facts
| Lead sponsor | Population Council |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 7 December 2022 |
| Primary completion | 11 September 2023 |
| Estimated completion | 11 September 2023 |
| Sites | 1 location across Zimbabwe |
Drugs / interventions tested
- Dual Prevention Pill — full drug profile →
- PrEP and combined oral contraceptive (COC) as two separate tablets — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
- Contraception — all drugs for Contraception →
Sponsor
Population Council
Who can join
Adults 16 to 24, female only, with HIV Infections or Contraception. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study design is a single-site, two-arm, randomized, open-label crossover trial in 30 AGYW aged 16-24 in Chitungwiza (Harare), Zimbabwe. The aim of the study is to assess the acceptability of, preference for, and adherence to a single DPP capsule containing one PrEP tablet and one COC tablet compared to two separate tablets (FTC/TDF and EE/LNG), each taken for three consecutive menstrual cycles for a total of 24 weeks among current COC users.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in
Friedland BA, Mgodi NM, Palanee-Phillips T, Mathur S, et al · · 2024 · cited 4× · PMID 38479746 · DOI 10.1136/bmjopen-2023-075381 -
A Dual Prevention Pill for HIV & Pregnancy Prevention: A Pilot Study Among Adolescent Girls and Young Women in Zimbabwe.
Mgodi NM, Burnett-Zieman JB, Murombedzi C, Dandadzi A, et al · · 2026 · PMID 41251867 · DOI 10.1007/s10461-025-04909-2 -
Adolescents' and young women's perspectives on participation in biomedical clinical trials for HIV prevention in Tanzania and India: A qualitative inquiry.
Pack AP, Jeon H, Kaaya S, Sastry J, et al · · 2025 · PMID 40894324 · DOI 10.1080/17450128.2025.2457037 -
Factors associated with women’s preference for an over-encapsulated Dual Prevention Pill: Findings from two clinical crossover trials among women in South Africa and Zimbabwe
Mathur S, Plagianos M, Friedland B, Bruce I, et al · · 2025 · DOI 10.21203/rs.3.rs-6683281/v1
Verify or expand the search:
- PubMed search for NCT04778514
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other Population Council trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04778514 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Population Council
- Last refreshed: 6 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04778514.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing