PrEP Implementation for Mothers in Antenatal Care

NCT03070600 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: STUDY000004381R01AI125498
• Study Type: interventional
• Target: 4,447
• Locations: 1 country
• Sites: 20

Brief Summary

In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP given to all women (similar to the approaches used for malaria prophylaxis), all women at risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is that a targeted PrEP model may be closer to perfect coverage than a universal offer/self-select model. Implementing targeted PrEP through strategies that include facilitation of partner testing with self-tests could add HIV prevention benefit by increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among pregnant women. By implementing these strategies and measuring uptake, use, and HIV incidence, we can inform the best health systems model for PrEP delivery in pregnancy.

Conditions

HIV Infections; Pregnancy Related

Keywords

PrEP

Outcome Measures

Primary Outcomes (2)

• Maternal HIV Incidence

  Maternal HIV Incidence

  6 weeks, 6 months, 9 months postpartum

• Appropriate PrEP Decision

  Scored 1 for high risk women using PrEP and low risk women not using PrEP; 0 for high risk women NOT on PrEP and low risk women using PrEP

  Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Secondary Outcomes (8)

• PrEP Adherence

  Enrollment to 9 months postpartum

• PrEP Duration

  Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

• Partner With Known HIV Status

  At 9 months postpartum

• Infant Birthweight

  time of delivery

• Infant Growth

  9 months of age

Other Outcomes (2)

• PrEP Adherence by Self-report

  Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

• Partner on ART if HIV Positive

  Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Study Arms (2)

Universal PrEP Counselling

ACTIVE COMPARATOR

All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP.

Other: Universal PrEP Counseling

Targeted PrEP Clinics

EXPERIMENTAL

All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling.

Other: Targeted PrEP Counseling

Interventions

Universal PrEP Counseling OTHER

Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.

Universal PrEP Counselling

Targeted PrEP Counseling OTHER

Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.

Targeted PrEP Clinics

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: All participants must be pregnant at time of enrollment.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility for enrollment will include age ≥15 years
• Pregnant at any gestational age
• Tuberculosis negative
• Plans to reside in area for at least one year postpartum
• Plans to receive postnatal and infant care at the study facility
• Not currently enrolled in any other studies.

You may not qualify if:

• HIV+ at time of enrollment

Sponsors & Collaborators

• University of Washington: lead
• Kenyatta National Hospital: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (20)

Ambira Hospital

Ambira, Kenya

Location

Bondo Subcounty Hospital

Bondo, Kenya

Location

Homabay Teaching and Referral Hospital

Homa Bay, Kenya

Location

Kandiege Subcounty Hospital

Kandege, Kenya

Location

Kendu Bay Subcounty Hospital

Kendu Bay, Kenya

Location

Madiany Subcounty Hospital

Madiany, Kenya

Location

Malanga Subcounty Hospital

Malanga, Kenya

Location

Marindi Subcounty Hospital

Marinde, Kenya

Location

Mbita Subcounty Hospital

Mbita, Kenya

Location

Ndhiwa Subcounty Hospital

Ndhiwa, Kenya

Location

Ober Subcounty Hospital

Ober, Kenya

Location

Ongielo Subcounty Hospital

Ongielo, Kenya

Location

Rachuonyo South Subcounty Hospital

Rachuonyo South, Kenya

Location

Rangwe Subcounty Hospital

Rangwe, Kenya

Location

Rwambwa Subcounty Hospital

Rwambwa, Kenya

Location

Siaya Teaching and Referral Hospital

Siaya, Kenya

Location

Suba Subcounty Hospital

Suba, Kenya

Location

Usigu Subcounty Hospital

Usigu, Kenya

Location

Uyawi Subcounty Hospital

Uyawi, Kenya

Location

Yala Subcounty Hospital

Yala, Kenya

Location

Related Publications (14)

• Dettinger JC, Kinuthia J, Pintye J, Mwongeli N, Gomez L, Richardson BA, Barnabas R, Wagner AD, O'Malley G, Baeten JM, John-Stewart G. PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial. BMJ Open. 2019 Mar 7;9(3):e025122. doi: 10.1136/bmjopen-2018-025122.

  PMID: 30850409 BACKGROUND

• Wagner AD, Kinuthia J, Dettinger J, Mwongeli N, Gomez L, Watoyi S, Drake AL, Abuna F, Pintye J, Ochieng B, Odinga D, John-Stewart G, Baeten JM. Challenges of Discrepant HIV Tests in Pregnant Women in the PrEP era-to Treat or Not to Treat? J Infect Dis. 2021 Feb 3;223(2):234-237. doi: 10.1093/infdis/jiaa343.

  PMID: 32561928 BACKGROUND

• Pintye J, Davey DLJ, Wagner AD, John-Stewart G, Baggaley R, Bekker LG, Celum C, Chi BH, Coates TJ, Groves AK, Haberer JE, Heffron R, Kinuthia J, Matthews LT, McIntyre JA, Moodley D, Mofenson LM, Mugo N, Mujugira A, Myer L, Shoptaw S, Stranix-Chibanda L, Baeten JM; PrEP in Pregnancy Working Group. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework. Lancet HIV. 2020 Aug;7(8):e582-e592. doi: 10.1016/S2352-3018(20)30102-8.

  PMID: 32763221 BACKGROUND

• Joseph Davey DL, Pintye J, Baeten JM, Aldrovandi G, Baggaley R, Bekker LG, Celum C, Chi BH, Coates TJ, Haberer JE, Heffron R, Kinuthia J, Matthews LT, McIntyre J, Moodley D, Mofenson LM, Mugo N, Myer L, Mujugira A, Shoptaw S, Stranix-Chibanda L, John-Stewart G; PrEP in Pregnancy Working Group. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading? J Int AIDS Soc. 2020 Jan;23(1):e25426. doi: 10.1002/jia2.25426.

  PMID: 31912985 BACKGROUND

• Dettinger JC, Pintye J, Dollah A, Awuor M, Abuna F, Lagat H, Kohler P, John-Stewart G, O'Malley G, Kinuthia J, Beima-Sofie K. Brief Report: "What Is This PrEP?"-Sources and Accuracy of HIV Pre-Exposure Prophylaxis (PrEP) Awareness Among Adolescent Girls and Young Women Attending Family Planning and Maternal Child Health Clinics in Western Kenya. J Acquir Immune Defic Syndr. 2021 Dec 1;88(4):356-360. doi: 10.1097/QAI.0000000000002782.

  PMID: 34379606 RESULT

• Nganga N, Dettinger J, Kinuthia J, Baeten J, John-Stewart G, Gomez L, Marwa M, Ochieng B, Pintye J, Mugwanya K, Mugambi M. Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya. PLoS One. 2021 Nov 12;16(11):e0258578. doi: 10.1371/journal.pone.0258578. eCollection 2021.

  PMID: 34767573 RESULT

• Escudero JN, Dettinger JC, Pintye J, Kinuthia J, Lagat H, Abuna F, Kohler P, Baeten JM, O'Malley G, John-Stewart GC, Beima-Sofie KM. Community Perceptions About Use of Pre-exposure Prophylaxis Among Adolescent Girls and Young Women in Kenya. J Assoc Nurses AIDS Care. 2020 Nov-Dec;31(6):669-677. doi: 10.1097/JNC.0000000000000191.

  PMID: 32675642 RESULT

• Pintye J, O'Malley G, Kinuthia J, Abuna F, Escudero JN, Mugambi M, Awuor M, Dollah A, Dettinger JC, Kohler P, John-Stewart G, Beima-Sofie K. Influences on Early Discontinuation and Persistence of Daily Oral PrEP Use Among Kenyan Adolescent Girls and Young Women: A Qualitative Evaluation From a PrEP Implementation Program. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):e83-e89. doi: 10.1097/QAI.0000000000002587.

  PMID: 33273211 RESULT

• Rogers Z, Pintye J, Kinuthia J, O'Malley G, Abuna F, Escudero J, Mugambi M, Awuor M, Dollah A, Dettinger JC, Kohler P, John-Stewart G, Beima-Sofie K. Key influences on the decision to initiate PrEP among adolescent girls and young women within routine maternal child health and family planning clinics in Western Kenya. AIDS Care. 2022 Mar;34(3):363-370. doi: 10.1080/09540121.2021.1981217. Epub 2021 Sep 20.

  PMID: 34543077 RESULT

• Gomez L, Kinuthia J, Abuna F, Baeten JM, Dettinger J, Larsen A, Marwa M, Ngumbau N, Odhiambo B, Omondi P, Stern J, Richardson BA, Watoyi S, John-Stewart G, Pintye J; PrEP Implementation for Mothers in Antenatal Care (PrIMA) Study Team. Prenatal exposure to HIV pre-exposure prophylaxis and birth, growth, and social-emotional developmental outcomes throughout early childhood in Kenya: a prospective cohort study. Lancet Glob Health. 2025 Mar;13(3):e467-e478. doi: 10.1016/S2214-109X(24)00471-6.

  PMID: 40021305 DERIVED

• Marwa MM, Larsen A, Abuna F, Dettinger J, Odhiambo B, Watoyi S, Omondi P, Ngumbau N, Gomez L, John-Stewart G, Kinuthia J, Pintye J. Brief Report: HIV Risk Perception and Pre-Exposure Prophylaxis Uptake Among Pregnant Women Offered Pre-Exposure Prophylaxis During Antenatal Care in Kenya. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):116-122. doi: 10.1097/QAI.0000000000003641.

  PMID: 39885623 DERIVED

• Ngumbau NM, Neary J, Wagner AD, Abuna F, Ochieng B, Dettinger JC, Gomez L, Marwa MM, Watoyi S, Nzove E, Pintye J, Baeten JM, Kinuthia J, John-Stewart G. Cofactors of Partner HIV Self-testing and Oral PrEP Acceptance Among Pregnant Women at High Risk of HIV in Kenya. J Acquir Immune Defic Syndr. 2024 Mar 1;95(3):238-245. doi: 10.1097/QAI.0000000000003355.

  PMID: 38408215 DERIVED

• Pintye J, Kinuthia J, Abuna F, Anderson PL, Dettinger JC, Gomez L, Haberer JE, Marwa MM, Ngumbau N, Omondi P, Odhiambo B, Stern J, Watoyi S, Baeten JM, John-Stewart G; PrEP Implementation for Mothers in Antenatal Care (PrIMA) Study Team. HIV pre-exposure prophylaxis initiation, persistence, and adherence during pregnancy through the postpartum period. AIDS. 2023 Sep 1;37(11):1725-1737. doi: 10.1097/QAD.0000000000003617. Epub 2023 Jun 6.

  PMID: 37289583 DERIVED

• Chen S, Pawelec G, Trompet S, Goldeck D, Mortensen LH, Slagboom PE, Christensen K, Gussekloo J, Kearney P, Buckley BM, Ford I, Jukema JW, Westendorp RGJ, Maier AB. Associations of Cytomegalovirus Infection With All-Cause and Cardiovascular Mortality in Multiple Observational Cohort Studies of Older Adults. J Infect Dis. 2021 Feb 3;223(2):238-246. doi: 10.1093/infdis/jiaa480.

  PMID: 32909605 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Low HIV incidence limited power of the primary outcome; however, similar HIV incidence in both arms suggest that meaningful differences are unlikely. Changing MoH policies and the COVID-19 pandemic affected study operations. Our observed rates of PrEP adherence and persistence could have been influenced by efforts to optimize study retention, and PrEP adherence relied on self-report, which can overestimate adherence.

Results Point of Contact

• Title: Grace John-Stewart
• Organization: University of Washington

gjohn@uw.edu

206-543-4278

Study Officials

• Grace John-Stewart, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jared Baeten, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• John Kinuthia, MBChB, MMed

  Kenyatta National Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Global Health

Model Details: We will select 20 clinics from Western Kenya. Ten clinics will be randomized to universal PrEP and ten to targeted PrEP (Table 2). To ensure balance between study arms in terms of key site characteristics, sites will be categorized on HIV prevalence and ANC volume, and restricted randomization will be used for site (cluster) allocation to intervention and control arms (68).

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Study Start: January 15, 2018
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: July 12, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-07

Locations

KE (20)