HIV-I Infection Clinical Trial
— PrEP-PPOfficial title:
Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women
| Verified date | March 2024 |
| Source | University of California, Los Angeles |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.
| Status | Active, not recruiting |
| Enrollment | 1195 |
| Est. completion date | June 1, 2024 |
| Est. primary completion date | February 9, 2023 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - >16 years of age, - confirmed HIV-negative (using 2 rapid tests, - confirmed with a 4th generation antigen HIV test; - lives within 20 km. of the clinic; - confirmed to be pregnant; - without psychiatric or medical contraindications to PrEP Exclusion Criteria: - Concurrent enrollment in another HIV-1 vaccine or prevention trial; - medical hospitalization in the past year for any reason; - receipt of TB treatment in the past 30 days; history of renal disease; - exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior), - currently or history of taking anti-psychotic medications; - positive Hepatitis B surface antigen test on screening; - history of bone fracture not related to trauma; - any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study. |
| Country | Name | City | State |
|---|---|---|---|
| South Africa | University of Cape Town | Cape Town | Western Cape |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Los Angeles | University of Cape Town |
South Africa,
Beesham I, Dovel K, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL. Barriers to Oral HIV Pre-exposure Prophylaxis (PrEP) Adherence Among Pregnant and Post-partum Women from Cape Town, South Africa. AIDS Behav. 2022 Sep;26(9):3079-3087 — View Citation
Beesham I, Mansoor LE, Joseph Davey DL, Palanee-Phillips T, Smit J, Ahmed K, Selepe P, Louw C, Singata-Madliki M, Kotze P, Heffron R, Parikh UM, Wiesner L, Rees H, Baeten JM, Beksinska M. Brief Report: Quantifiable Plasma Tenofovir Among South African Wom — View Citation
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 — View Citation
Joseph Davey D, Hsiao NY, Wendy Spearman C, Sonderup M, Hu NC, Mashele N, Mvududu R, Myer L. Low prevalence of hepatitis B virus infection in HIV-uninfected pregnant women in Cape Town, South Africa: implications for oral pre-exposure prophylaxis roll out — View Citation
Joseph Davey D, Nyemba DC, Castillo-Mancilla J, Wiesner L, Norman J, Mvududu R, Mashele N, Johnson LF, Bekker LG, Gorbach P, Coates TJ, Myer L. Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in Sou — View Citation
Joseph Davey DL, Bekker LG, Bukusi EA, Chi BH, Delany-Moretlwe S, Goga A, Lyerly AD, Mgodi NM, Mugo N, Myer L, Noguchi LM, Stranix-Chibanda L, Slack C, Pintye J. Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The im — View Citation
Joseph Davey DL, Daniels J, Beard C, Mashele N, Bekker LG, Dovel K, Ncayiyana J, Coates TJ, Myer L. Healthcare provider knowledge and attitudes about pre-exposure prophylaxis (PrEP) in pregnancy in Cape Town, South Africa. AIDS Care. 2020 Oct;32(10):1290-1294. doi: 10.1080/09540121.2020.1782328. Epub 2020 Jun 23. — View Citation
Joseph Davey DL, Dovel K, Mvududu R, Nyemba D, Mashele N, Bekker LG, Gorbach PM, Coates TJ, Myer L. Pre-exposure Prophylaxis Recent Adherence With Real-Time Adherence Feedback and Partner Human Immunodeficiency Virus Self-Testing: A Pilot Trial Among Post — View Citation
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 — View Citation
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 — View Citation
Joseph Davey DL, Wilkinson L, Grimsrud A, Nelson A, Gray A, Raphael Y, Wattrus C, Pillay Y, Bekker LG. Urgent appeal to allow all professional nurses and midwives to prescribe pre-exposure prophylaxis (PrEP) in South Africa. S Afr Med J. 2023 Aug 3;113(8) — View Citation
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 — View Citation
Li KT, Li F, Jaspan H, Nyemba D, Myer L, Aldrovandi G, Joseph-Davey D. Changes in the Vaginal Microbiome During Pregnancy and the Postpartum Period in South African Women: a Longitudinal Study. Reprod Sci. 2024 Jan;31(1):275-287. doi: 10.1007/s43032-023-0 — View Citation
Miller AP, Shoptaw S, Mvududu R, Mashele N, Coates TJ, Bekker LG, Essack Z, Groenewald C, Petersen Z, Gorbach PM, Myer L, Joseph Davey DL. Sexual Risk among Pregnant Women at Risk of HIV Infection in Cape Town, South Africa: What Does Alcohol Have to Do w — View Citation
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 — View Citation
* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participants Initiating Pre-exposure Prophylaxis During Pregnancy | Percentage of participants initiating pre-exposure prophylaxis during pregnancy | Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant | |
| Primary | Adherence to TDF at 3-months on PrEP | Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 3 months on PrEP | Measured at 3 month follow up visit | |
| Primary | Women Initiating Pre-exposure Prophylaxis Post-partum | Percentage of women initiating pre-exposure prophylaxis | Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth | |
| Primary | Adherence to TDF at 6 Months Post-partum | Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 6 month post-partum visit | Measured at 6-month post-partum visit | |
| Primary | Number of Participants With Adherence to TFV-DP at 6-month Visit | Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months | Measured at 6-month study visit | |
| Secondary | PrEP Initiation Among Those With STI POC Testing vs Syndromic Management | Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP | Measured at enrollment and 1 month follow up |