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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI125498 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenyatta National Hospital | OTHER_GOV |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrollment to 9 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence by Self-report | Any missed doses in the last month reported by participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
| Partner on ART if HIV Positive |
Inclusion Criteria:
Exclusion Criteria:
All participants must be pregnant at time of enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambira Hospital | Ambira | Kenya | ||||
| Bondo Subcounty Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30850409 | Background | 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. | |
| 32561928 | 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. |
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Enrollment ended on July 31, 2019. At that time 4,447 women had enrolled (consented) into the PrIMA study out of an anticipated 4,500.
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| ID | Title | Description |
|---|---|---|
| FG000 | Universal PrEP Counselling | 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. Universal PrEP Counseling: 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. |
| FG001 | Targeted PrEP Clinics | 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. Targeted PrEP Counseling: 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrollment for this study ended on July 31, 2019. At the time that enrollment ended, 4,447 participants had enrolled (consented) into the study out of an anticipated 4,500.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Universal PrEP Counselling | 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. Universal PrEP Counseling: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal HIV Incidence | Maternal HIV Incidence | Posted | Number | 95% Confidence Interval | incidence/100 Person years | 6 weeks, 6 months, 9 months postpartum | Person-Time (years) | Person-Time (years) |
|
Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Universal PrEP Counselling | 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. Universal PrEP Counseling: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infant Death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Participant experienced a neonatal or infant death during the study period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kicked out of home | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace John-Stewart | University of Washington | 206-543-4278 | gjohn@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2019 | Feb 8, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2021 | Mar 15, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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).
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|
| 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:
|
|
| PrEP Duration |
Number of months on PrEP |
| 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 | At 9 months postpartum |
| Infant Birthweight | Infant Birthweight | 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. | 9 months of age |
| PrEP Use | PrEP Utilization by participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
| PrEP Acceptance | PrEP accepted by participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
| Preterm Birth | Birth <37 weeks gestation | At birth |
Participant report of partner ART use if partner is HIV positive
| Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
| Bondo |
| Kenya |
| Homabay Teaching and Referral Hospital | Homa Bay | Kenya |
| Kandiege Subcounty Hospital | Kandege | Kenya |
| Kendu Bay Subcounty Hospital | Kendu Bay | Kenya |
| Madiany Subcounty Hospital | Madiany | Kenya |
| Malanga Subcounty Hospital | Malanga | Kenya |
| Marindi Subcounty Hospital | Marinde | Kenya |
| Mbita Subcounty Hospital | Mbita | Kenya |
| Ndhiwa Subcounty Hospital | Ndhiwa | Kenya |
| Ober Subcounty Hospital | Ober | Kenya |
| Ongielo Subcounty Hospital | Ongielo | Kenya |
| Rachuonyo South Subcounty Hospital | Rachuonyo South | Kenya |
| Rangwe Subcounty Hospital | Rangwe | Kenya |
| Rwambwa Subcounty Hospital | Rwambwa | Kenya |
| Siaya Teaching and Referral Hospital | Siaya | Kenya |
| Suba Subcounty Hospital | Suba | Kenya |
| Usigu Subcounty Hospital | Usigu | Kenya |
| Uyawi Subcounty Hospital | Uyawi | Kenya |
| Yala Subcounty Hospital | Yala | Kenya |
| 32763221 | 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. |
| 31912985 | 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. |
| 34379606 | Result | 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. |
| 34767573 | 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. |
| 32675642 | 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. |
| 33273211 | 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. |
| 34543077 | 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. |
| 40021305 | Derived | 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. |
| 39885623 | 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. |
| 38408215 | 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. |
| 37289583 | 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. |
| 32909605 | 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. |
| BG001 | Targeted PrEP Clinics | 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. Targeted PrEP Counseling: 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:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Targeted PrEP Clinics | 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. Targeted PrEP Counseling: 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:
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| Secondary | 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. | Of the 186 participants sampled for this analyses, 427 DBS samples were analyzed (232 universal arm, 195 targeted arm). | Posted | Number | Samples w/ adherence at ~7dose/week | Enrollment to 9 months postpartum | DBS Samples | DBS Samples |
|
|
|
| Secondary | PrEP Duration | Number of months on PrEP | This analysis is restricted to participants who initiated PrEP during the study period. | Posted | Median | Inter-Quartile Range | months | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| Secondary | Partner With Known HIV Status | Participants report of partner's HIV status | This analysis is restricted to participants who reported having a partner at 9-months postpartum. | Posted | Count of Participants | Participants | At 9 months postpartum |
|
|
|
| Secondary | Infant Birthweight | Infant Birthweight | This analysis is restricted to mothers with live born infants with birth weight data available in their clinical records. | Posted | Median | Inter-Quartile Range | kg | time of delivery |
|
|
|
| Secondary | 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. | Length measurements could not be ascertained from all infants | Posted | Median | Inter-Quartile Range | z-score | 9 months of age |
|
|
|
| Secondary | PrEP Use | PrEP Utilization by participants | Posted | Count of Participants | Participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| Secondary | PrEP Acceptance | PrEP accepted by participants | Posted | Count of Participants | Participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| Secondary | Preterm Birth | Birth <37 weeks gestation | This analysis is restricted to participants who reported a live birth and had gestational age at birth data available. | Posted | Count of Participants | Participants | At birth |
|
|
|
| Other Pre-specified | PrEP Adherence by Self-report | Any missed doses in the last month reported by participants | Posted | Count of Participants | Participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| Other Pre-specified | Partner on ART if HIV Positive | Participant report of partner ART use if partner is HIV positive | This analysis is restricted to participants with a partner known to be living with HIV. | Posted | Count of Participants | Participants | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). |
|
|
|
| 2 |
| 2,250 |
| 132 |
| 2,250 |
| 7 |
| 2,250 |
| EG001 | Targeted PrEP Clinics | 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. Targeted PrEP Counseling: 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:
| 2 | 2,197 | 118 | 2,197 | 7 | 2,197 |
|
| Infant Hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Participant experienced an infant hospitalization during the study period |
|
| Maternal Hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Participant was hospitalized during the study period |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Loss of pregnancy before 20 weeks gestational age |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Loss of pregnancy after 20 weeks gestational age |
|
| Molar Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Experienced violence of abuse | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Breach of confidentiality | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Suicidal behavior | Psychiatric disorders | Non-systematic Assessment |
|
| Persistent or significant psychosocial distress | Psychiatric disorders | Non-systematic Assessment |
|
| Partner thought participant was HIV positive | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Infant HAZ at 9mo PP |
|
|
| Infant WHZ at 9mo PP |
|
|