HIV InfectionsPhase 4PrIMANCT03070600
PrEP Implementation for Mothers in Antenatal Care
A Phase 4 study testing Universal PrEP Counseling and Targeted PrEP Counseling in people with HIV Infections and Pregnancy Related, run by University of Washington at 20 sites in Kenya.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- HIV Infections, Pregnancy Related
- What is being tested?
- Universal PrEP Counseling and Targeted PrEP Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,447 participants
- Where
- 20 sitesKenya
- Study dates
- 15 Jan 2018to 15 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- HIV+ at time of enrollment
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Kenya20 sites
Ambira Hospital
Ambira
Bondo Subcounty Hospital
Bondo
Homabay Teaching and Referral Hospital
Homa Bay
Kandiege Subcounty Hospital
Kandege
Kendu Bay Subcounty Hospital
Kendu Bay
Madiany Subcounty Hospital
Madiany
Malanga Subcounty Hospital
Malanga
Marindi Subcounty Hospital
Marinde
Mbita Subcounty Hospital
Mbita
Ndhiwa Subcounty Hospital
Ndhiwa
Ober Subcounty Hospital
Ober
Ongielo Subcounty Hospital
Ongielo
Rachuonyo South Subcounty Hospital
Rachuonyo South
Rangwe Subcounty Hospital
Rangwe
Rwambwa Subcounty Hospital
Rwambwa
Siaya Teaching and Referral Hospital
Siaya
Suba Subcounty Hospital
Suba
Usigu Subcounty Hospital
Usigu
Uyawi Subcounty Hospital
Uyawi
Yala Subcounty Hospital
Yala
About this study
Official title: Delivering PrEP in Pregnancy
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.
Read the detailed description
Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner's HIV status, and have biologic changes or changes in their partner's sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) may be an attractive strategy for HIV prevention in pregnancy/postpartum; however, it is important to ensure PrEP reaches women who are at risk for acquiring HIV during pregnancy while avoiding unnecessary PrEP use during pregnancy. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. This cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, up to 250 women per clinic, up to 5000 women overall), will compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal availability of PrEP (and women self-select whether to use) or targeted offer of PrEP (i.e., offer to women identified as high risk through a standardized risk assessment and partner self-testing, and then women identified as high-risk select whether to use). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost-effectiveness. Our team has expertise in maternal-child HIV (John-Stewart, Kinuthia), PrEP clinical trials and implementation science (Baeten, Richardson), partner self-testing (Thirumurthy), economics and qualitative research (Barnabas, O'Malley).
AIM 1a. In a cluster-RCT, compare universal PrEP (offer to all; women self-select PrEP) to targeted PrEP (limit the offer to women identified as high risk through a standardized risk assessment and partner self-testing) for outcomes reflecting the balance of PrEP effectiveness and avoiding unnecessary PrEP exposure to women at low or no risk of HIV: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP.
AIM 1b. To compare trial arms for proportion of women 'appropriately' on PrEP (risk factors), PrEP adherence (drug levels) and duration, partners with known HIV status, partners on ART; infant outcomes (growth, birth outcomes, HIV status).
AIM 2. To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and postpartum, per HIV infection and disability-adjusted life-year (DALY) averted.
AIM 3. To qualitatively assess barriers and facilitators to uptake, adherence, acceptability, and feasibility in universal and targeted PrEP models at the organizational, provider, and individual woman level.
- Conditions
- HIV Infections, Pregnancy Related
- Being tested
- Universal PrEP Counseling, Targeted PrEP Counseling
- Keywords
- PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal PrEP CounselingOther
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.
Targeted PrEP CounselingOther
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:
- 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
- participant declines partner self-tests regardless of partner HIV status, and/or
- their partner declines self-testing or tests positive.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Targeted PrEP Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal HIV Incidence
Maternal HIV Incidence
Measured: 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
Measured: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Secondary outcomes (8)
PrEP Adherence
Sequential dried blood spots, PrEP adherence by DBS dichotomous by pregnancy or postpartum thresholds equivalent to ~7 doses per week (≥650 fmol/punch during pregnancy or ≥950 fmol/punch postpartum) based on the thresholds established by the 2009 IMPAACT directly observed PrEP PK study.
Measured: Enrollment to 9 months postpartum
PrEP Duration
Number of months on PrEP
Measured: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Partner With Known HIV Status
Participants report of partner's HIV status
Measured: At 9 months postpartum
Infant Birthweight
Infant Birthweight
Measured: time of delivery
Infant Growth
Infant height, weight, and age (Weight-for-Age [WAZ], Height-for-Age [HAZ], Weight-for-Height [WHZ] Z-scores). A Z-score of 0 represents the population mean. Indicators of infant malnutrition are defined as Underweight- WAZ Z-score<-2; Stunting-HAZ Z-Score <-2; Wasting- WHZ Z-Score <-2.
Measured: 9 months of age
PrEP Use
PrEP Utilization by participants
Measured: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
PrEP Acceptance
PrEP accepted by participants
Measured: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Preterm Birth
Birth <37 weeks gestation
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start15 Jan 2018
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 4,447 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Grace John-Stewart, University of Washington
- Investigators
- Grace John-Stewart, MD, PhD, Principal investigator, University of WashingtonJared Baeten, MD, PhD, Principal investigator, University of WashingtonJohn Kinuthia, MBChB, MMed, Study director, Kenyatta National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070600
- Sponsor's protocol ID
- STUDY00000438
- Other IDs
- 1R01AI125498
- Acronym
- PrIMA
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2017
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 30850409Wagner 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.
PubMed 32561928Pintye 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.
PubMed 32763221Joseph 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.
PubMed 31912985Dettinger 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.
PubMed 34379606Nganga 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.
PubMed 34767573Escudero 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.
PubMed 32675642Pintye 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.
PubMed 33273211Rogers 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.
PubMed 34543077Gomez 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.
PubMed 40021305Marwa 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.
PubMed 39885623Ngumbau 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.
PubMed 38408215Pintye 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.
PubMed 37289583Chen 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.
PubMed 32909605
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering PrEP in Pregnancy
- ClinicalTrials.gov ID
- NCT03070600
- Acronym / sponsor ID
- PrIMA / STUDY00000438
- Conditions
- HIV Infections, Pregnancy Related
- Keywords
- PrEP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,447 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner's HIV status, and have biologic changes or changes in their partner's sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) may be an attractive strategy for HIV prevention in pregnancy/postpartum; however, it is important to ensure PrEP reaches women who are at risk for acquiring HIV during pregnancy while avoiding unnecessary PrEP use during pregnancy. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. This cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, up to 250 women per clinic, up to 5000 women overall), will compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal availability of PrEP (and women self-select whether to use) or targeted offer of PrEP (i.e., offer to women identified as high risk through a standardized risk assessment and partner self-testing, and then women identified as high-risk select whether to use). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost-effectiveness. Our team has expertise in maternal-child HIV (John-Stewart, Kinuthia), PrEP clinical trials and implementation science (Baeten, Richardson), partner self-testing (Thirumurthy), economics and qualitative research (Barnabas, O'Malley).
AIM 1a. In a cluster-RCT, compare universal PrEP (offer to all; women self-select PrEP) to targeted PrEP (limit the offer to women identified as high risk through a standardized risk assessment and partner self-testing) for outcomes reflecting the balance of PrEP effectiveness and avoiding unnecessary PrEP exposure to women at low or no risk of HIV: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP.
AIM 1b. To compare trial arms for proportion of women 'appropriately' on PrEP (risk factors), PrEP adherence (drug levels) and duration, partners with known HIV status, partners on ART; infant outcomes (growth, birth outcomes, HIV status).
AIM 2. To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and postpartum, per HIV infection and disability-adjusted life-year (DALY) averted.
AIM 3. To qualitatively assess barriers and facilitators to uptake, adherence, acceptability, and feasibility in universal and targeted PrEP models at the organizational, provider, and individual woman level.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Universal PrEP Counselling | Active comparator | Other: Universal PrEP CounselingAll 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. |
| Targeted PrEP Clinics | Experimental | Other: Targeted PrEP CounselingAll 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- HIV+ at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal PrEP CounselingCounseling 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. | Other | Universal PrEP Counselling |
| Targeted PrEP CounselingFollowing 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. | Other | Targeted PrEP Clinics |
Primary outcome
Maternal HIV Incidence
Time frame: 6 weeks, 6 months, 9 months postpartum
Maternal HIV Incidence
Appropriate PrEP Decision
Time frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
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
8 secondary outcomes
PrEP Adherence
Time frame: Enrollment to 9 months postpartum
PrEP Duration
Time frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Partner With Known HIV Status
Time frame: At 9 months postpartum
Infant Birthweight
Time frame: time of delivery
Infant Growth
Time frame: 9 months of age
PrEP Use
Time frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
PrEP Acceptance
Time frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Preterm Birth
Time frame: At birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30850409Dettinger 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.
- Background: PubMed 32561928Wagner 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.
- Background: PubMed 32763221Pintye 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.
- Background: PubMed 31912985Joseph 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.
- Results publication: PubMed 34379606Dettinger 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.
- Results publication: PubMed 34767573Nganga 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.
- Results publication: PubMed 32675642Escudero 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.
- Results publication: PubMed 33273211Pintye 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.
- Results publication: PubMed 34543077Rogers 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.
- Derived from this study: PubMed 40021305Gomez 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.
- Derived from this study: PubMed 39885623Marwa 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.
- Derived from this study: PubMed 38408215Ngumbau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace John-Stewart, MD, PhD principal investigator
University of Washington
Jared Baeten, MD, PhD principal investigator
University of Washington
John Kinuthia, MBChB, MMed study director
Kenyatta National Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Universal PrEP Counseling and Targeted PrEP Counseling in people with HIV Infections and Pregnancy Related, run by University of Washington at 20 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal HIV Incidence (time frame: 6 weeks, 6 months, 9 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070600, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.