Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006650810423 Date of Approval: 11/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PrEP Implementation of Mothers in Antenatal care
Official scientific title PrEP Implementation of Mothers in Antenatal care
Brief summary describing the background and objectives of the trial 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. With mandatory PrEP given to all women, 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, process, and HIV incidence, we can inform the best health systems model for PrEP delivery in pregnancy. OBJECTIVES AIM 1a. To 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 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
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PrIMA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 04/09/2017
Actual trial start date 15/01/2018
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 30/04/2021
Anticipated target sample size (number of participants) 5000
Actual target sample size (number of participants) 4451
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.ncbi.nlm.nih.gov/pubmed/30850409
Secondary Ids Issuing authority/Trial register
P73 02 2017 KNH UoN ERC
PPB ECCT 18 11 01 Pharmacy and Poisons Board
STUDY00000438 University of Washington Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Universal arm N/A From enrolment upto 9 months postpartum 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. Women who select PrEP will be welcome to involve their partners in counseling regarding PrEP and those with recently diagnosed HIV positive male partners (via the clinic referral system) will linked to care following the facilities standard linkage to care procedures 2252 Active-Treatment of Control Group
Experimental Group Targeted arm N/A. PrEP is being dispensed according to the Ministry of Health guidelines From enrolment upto 9 months postpartum Following informed consent and enrollment data collection, the targeted PrEP clinics will provide two inter-related innovations: risk assessment-informed PrEP counselling and partner HIV Self-Test counselling.The results of the PrEP risk assessment will be used to guide PrEP counselling and the offer of proceeding to the PrEP card-based eligibility assessment. Participants who score greater than 6 on the risk assessment will receive additional PrEP counselling that includes information about specific risk factors tailored to the participant. These participants will then elect whether to proceed to the PrEP card eligibility assessment. Women who score 6 or less will not be individually counseled about PrEP. However, if they ask for PrEP they will enter the clinical assessment pathway and can be prescribed PrEP if found to be clinically eligible.Women will be offered HIV self-test kits to take to their partner for HIV testing. This will be used to provide further information on partner HIV-status: either initiate women in previously unidentified serodiscordant couples on PrEP at subsequent study visits, or to discontinue PrEP for women who are able to confirm their partner’s HIV-negative status. 2199
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. HIV+ at time of enrollment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2017 Kenyatta National Hospital and University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 20723, P.O. Box 19676 Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/04/2019 Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
LENANA ROAD P.O. BOX 27663 Nairobi 00506 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal HIV Incidence 6 weeks, 6 months, 9 months postpartum
Secondary Outcome Appropriate PrEP Use. 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
Secondary Outcome PrEP Adherence and duration on PrEP through sequential dried blood spots and number of days on PrEP Enrolment to 9 months postpartum
Secondary Outcome Infant birthweight, preterm birth, and growth curves. To compare infant outcomes in PrEP exposed infants vs. unexposed; Time of delivery unto 9 months of age
Secondary Outcome To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and in the postpartum period, per incident HIV infection and disability adjusted life year (DALY) averted. Enrolment to 9 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ambira subcounty hospital Siaya County Siaya Kenya
Usigu subcounty hospital Siaya county Siaya Kenya
Malanga subcounty hospital Siaya county Siaya Kenya
Uyawi subcounty hospital Siaya county Siaya Kenya
Rwambwa subcounty hospital Siaya County Siaya Kenya
Ongielo subcounty hospital Siaya county Siaya Kenya
Siaya county referral hospital Siaya county Siaya Kenya
Yala subcounty hospital Siaya county Siaya Kenya
Bondo county hospital Siaya county Siaya Kenya
Madiany subcounty hospital Siaya county Siaya Kenya
Ndhiwa subcounty hospital HomaBay county HomaBay Kenya
HomaBay County Teaching and referral hospital HomaBay county HomaBay Kenya
Kendu Bay subcounty hospital HomaBay county HomaBay Kenya
Rachuonyo South subcounty hospital HomaBay county HomaBay Kenya
Ober subcounty hospital HomaBay county HomaBay Kenya
Suba subcounty hospital HomaBay county HomaBay Kenya
Rangwe subcounty hospital HomaBay county HomaBay Kenya
Mbita subcounty hospital HomaBay county HomaBay Kenya
Marindi subcounty hospital HomaBay county HomaBay Kenya
Kandiege subcounty hospital HomaBay county HomaBay Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Allergy and Infectious Disease 10 Center Drive Bethesda Bethesda 20892 United States of America
The Eunice Kennedy Shriver National Institute of Child Health and Human Development 10 centre Drive Bethesda Bethesda 20892 United States of America
National Institute of Nursing Research 10 Centre Drive Bethesda Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Health 10 centre Drive Bethesda 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University of Washington 1410 NE Campus Parkway Seattle 98195 United States of America
Kenyatta National Hospital P.O Box 20723 Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grace John Stewart gjohn@uw.edu +12065434278 Harborview Medical Centre 325 Ninth Avenue
City Postal code Country Position/Affiliation
Seattle 98104 United States of America Professor Departments of Global Health Medicine Epidemiology and Paediatrics
Role Name Email Phone Street address
Principal Investigator Jared Baeten jbaeten@uw.edu +12065203808 Harborview Medical Center, 325 Ninth Avenue
City Postal code Country Position/Affiliation
Seattle 98104 United States of America Vice Chair Departments of Global Health Medicine and Epidemiology
Role Name Email Phone Street address
Scientific Enquiries John Kinuthia kinuthia@uw.edu +254722799052 Kenyatta National Hospital P.O. Box 20723
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Head of Department of Research and Programs at Kenyatta National Hospital
Role Name Email Phone Street address
Public Enquiries Nancy Ngumbau nancym390@gmail.com 254713917226 Kenyatta National Hospital P.O. Box 20723
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Study coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Government or university staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, participant records may be examined. The reviewers will protect participant's privacy. The study records will not be used to put participants at legal risk of harm. Study records may be reviewed by: • Kenyatta National Hospital and University of Nairobi, including Ethics and Research Committee • University of Washington, including Institutional Review Board • National Institutes of Health (NIH), United States A description of this trial will be available on http://www.clinicaltrials.gov, as is required by U.S. Law. This website will not include information that can identify participants. At most, the website will include a summary of results. Study Protocol During or after study N/A
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information