NCT03826199 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Haribhai S, Khadka N, Mvududu R, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL
Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study
Joseph Davey D, Myer L, Coates T
PrEP implementation in pregnant and post-partum women. Lancet HIV. 2020 Jan;7(1):e5-e6. doi: 10.1016/S2352-3018(19)30371-6. Epub 2019 Dec 5. No abstract available.
Joseph Davey DL, Knight L, Markt-Maloney J, Tsawe N, Gomba Y, Mashele N, Dovel K, Gorbach P, Bekker LG, Coates TJ, Myer L
"I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape T
Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, Khadka N, Bekker LG, Gorbach P, Coates TJ, Myer L
Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. J Int
Khadka N, Gorbach PM, Nyemba DC, Mvududu R, Mashele N, Javanbakht M, Nianogo RA, Aldrovandi GM, Bekker LG, Coates TJ, Myer L, Joseph Davey DL
Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young wom
Moran A, Mashele N, Mvududu R, Gorbach P, Bekker LG, Coates TJ, Myer L, Joseph Davey D
Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence. AIDS Behav. 2022 Jan;26(1):205-217. doi

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)

Clinical trial NCT03826199 - References