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Observational Study
. 2024 Sep 27;24(1):2604.
doi: 10.1186/s12889-024-20029-3.

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol

Friday Saidi  1   2   3 , Sanya Shah  4   5 , Madeleine Squibb  6 , Lameck Chinula  4   7   8 , Charity Nakanga  4 , Tisungane Mvalo  4   9 , Mitch Matoga  4 , Agatha K Bula  4 , Maganizo B Chagomerana  4   10 , Funny Kamanga  4 , Wiza Kumwenda  4 , Tawonga Mkochi  4 , Gladwell Masiye  4 , Ida Moya  4 , Michael E Herce  10 , Sarah E Rutstein  11 , Virginia Thonyiwa  12 , Rose K Nyirenda  13 , Victor Mwapasa  14 , Irving Hoffman  4   10 , Mina C Hosseinipour  4   10   11
Affiliations
Observational Study

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol

Friday Saidi et al. BMC Public Health. .

Abstract

Background: Incident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi.

Methods: PrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA's safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality.

Discussion: The PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region.

Trial registration number: NCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

Keywords: Birth outcomes; Cabotegravir; HIV prevention; Infant, and maternal health outcomes; Pre-exposure prophylaxis.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials flow diagram of prospective safety cohort. Abbreviations: ANC, Antenatal Care; PrEP, pre-exposure prophylaxis; CAB-LA, cabotegravir long-acting injectable PrEP; IDI, in-depth interview
Fig. 2
Fig. 2
Estimated total sample size for the prospective cohort
See this image and copyright information in PMC

References

    1. Hoffman RM, Angelidou K (Nadia), Brummel SS, Saidi F, Violari A, Dula. Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial. HIV Clin Trials. 2018;19(6):209–24. - PMC - PubMed
    1. Miro JM, Manzardo C, Mussini C, Johnson M, d’Arminio Monforte A, Antinori A, et al. Survival outcomes and effect of early vs. deferred cART among HIV-Infected patients diagnosed at the time of an AIDS-Defining event: a cohort analysis. PLoS ONE. 2011;6(10):e26009. - PMC - PubMed
    1. Cohen Myron S, Chen Ying Q, McCauley Marybeth G, Theresa, Hosseinipour Mina C, Nagalingeswaran K, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505. - PMC - PubMed
    1. Becquet R, Bland R, Ekouevi DK, Dabis F, Newell ML. Universal antiretroviral therapy among pregnant and postpartum HIV-infected women would improve maternal health and decrease postnatal HIV transmission. AIDS. 2010;24(8):1239. - PMC - PubMed
    1. Twabi HS, Manda SO, Small DS. Assessing the effects of maternal HIV infection on pregnancy outcomes using cross-sectional data in Malawi. BMC Public Health. 2020;20(1):974. - PMC - PubMed

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