PrEP Implementation for Mothers in Antenatal Care (PrIMA)
Primary Purpose
HIV Infections, Pregnancy Related
Status
Completed
Phase
Phase 4
Locations
Kenya
Study Type
Interventional
Intervention
Universal PrEP Counseling
Targeted PrEP Counseling
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring PrEP
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- HIV+ at time of enrollment
Sites / Locations
- Ambira Hospital
- Bondo Subcounty Hospital
- Homabay Teaching and Referral Hospital
- Kandiege Subcounty Hospital
- Kendu Bay Subcounty Hospital
- Madiany Subcounty Hospital
- Malanga Subcounty Hospital
- Marindi Subcounty Hospital
- Mbita Subcounty Hospital
- Ndhiwa Subcounty Hospital
- Ober Subcounty Hospital
- Ongielo Subcounty Hospital
- Rachuonyo South Subcounty Hospital
- Rangwe Subcounty Hospital
- Rwambwa Subcounty Hospital
- Siaya Teaching and Referral Hospital
- Suba Subcounty Hospital
- Usigu Subcounty Hospital
- Uyawi Subcounty Hospital
- Yala Subcounty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Universal PrEP Counselling
Targeted PrEP Clinics
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Maternal HIV Incidence
Maternal HIV Incidence
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
Secondary Outcome Measures
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.
PrEP Duration
Number of months on PrEP
Partner With Known HIV Status
Participants report of partner's HIV status
Infant Birthweight
Infant Birthweight
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.
PrEP Use
PrEP Utilization by participants
PrEP Acceptance
PrEP accepted by participants
Preterm Birth
Birth <37 weeks gestation
Full Information
NCT ID
NCT03070600
First Posted
February 27, 2017
Last Updated
July 11, 2022
Sponsor
University of Washington
Collaborators
Kenyatta National Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT03070600
Brief Title
PrEP Implementation for Mothers in Antenatal Care
Acronym
PrIMA
Official Title
Delivering PrEP in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Kenyatta National Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy Related
Keywords
PrEP
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
4447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Universal PrEP Counselling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Targeted PrEP Clinics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Universal PrEP Counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Targeted PrEP Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal HIV Incidence
Description
Maternal HIV Incidence
Time Frame
6 weeks, 6 months, 9 months postpartum
Title
Appropriate PrEP Decision
Description
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
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Secondary Outcome Measure Information:
Title
PrEP Adherence
Description
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.
Time Frame
Enrollment to 9 months postpartum
Title
PrEP Duration
Description
Number of months on PrEP
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Title
Partner With Known HIV Status
Description
Participants report of partner's HIV status
Time Frame
At 9 months postpartum
Title
Infant Birthweight
Description
Infant Birthweight
Time Frame
time of delivery
Title
Infant Growth
Description
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.
Time Frame
9 months of age
Title
PrEP Use
Description
PrEP Utilization by participants
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Title
PrEP Acceptance
Description
PrEP accepted by participants
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Title
Preterm Birth
Description
Birth <37 weeks gestation
Time Frame
At birth
Other Pre-specified Outcome Measures:
Title
PrEP Adherence by Self-report
Description
Any missed doses in the last month reported by participants
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Title
Partner on ART if HIV Positive
Description
Participant report of partner ART use if partner is HIV positive
Time Frame
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All participants must be pregnant at time of enrollment.
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
HIV+ at time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace John-Stewart, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jared Baeten, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBChB, MMed
Organizational Affiliation
Kenyatta National Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ambira Hospital
City
Ambira
Country
Kenya
Facility Name
Bondo Subcounty Hospital
City
Bondo
Country
Kenya
Facility Name
Homabay Teaching and Referral Hospital
City
Homa Bay
Country
Kenya
Facility Name
Kandiege Subcounty Hospital
City
Kandiege
Country
Kenya
Facility Name
Kendu Bay Subcounty Hospital
City
Kendu Bay
Country
Kenya
Facility Name
Madiany Subcounty Hospital
City
Madiany
Country
Kenya
Facility Name
Malanga Subcounty Hospital
City
Malanga
Country
Kenya
Facility Name
Marindi Subcounty Hospital
City
Marindi
Country
Kenya
Facility Name
Mbita Subcounty Hospital
City
Mbita
Country
Kenya
Facility Name
Ndhiwa Subcounty Hospital
City
Ndhiwa
Country
Kenya
Facility Name
Ober Subcounty Hospital
City
Ober
Country
Kenya
Facility Name
Ongielo Subcounty Hospital
City
Ongielo
Country
Kenya
Facility Name
Rachuonyo South Subcounty Hospital
City
Rachuonyo South
Country
Kenya
Facility Name
Rangwe Subcounty Hospital
City
Rangwe
Country
Kenya
Facility Name
Rwambwa Subcounty Hospital
City
Rwambwa
Country
Kenya
Facility Name
Siaya Teaching and Referral Hospital
City
Siaya
Country
Kenya
Facility Name
Suba Subcounty Hospital
City
Suba
Country
Kenya
Facility Name
Usigu Subcounty Hospital
City
Usigu
Country
Kenya
Facility Name
Uyawi Subcounty Hospital
City
Uyawi
Country
Kenya
Facility Name
Yala Subcounty Hospital
City
Yala
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
30850409
Citation
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.
Results Reference
background
PubMed Identifier
32561928
Citation
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.
Results Reference
background
PubMed Identifier
32763221
Citation
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.
Results Reference
background
PubMed Identifier
31912985
Citation
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.
Results Reference
background
PubMed Identifier
34379606
Citation
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.
Results Reference
result
PubMed Identifier
34767573
Citation
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.
Results Reference
result
PubMed Identifier
32675642
Citation
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.
Results Reference
result
PubMed Identifier
33273211
Citation
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.
Results Reference
result
PubMed Identifier
34543077
Citation
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.
Results Reference
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PubMed Identifier
32909605
Citation
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.
Results Reference
derived
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PrEP Implementation for Mothers in Antenatal Care
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