Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394323
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe Malawi
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
UNCPM 22323 - Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe Malawi a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose The overall objective of this pilot study is to evaluate the feasibility acceptability and appropriateness of a shared decision-making SDM intervention to support personally appropriate decision making about PrEP use during pregnancy and breastfeeding
Participants The primary population to be recruited for this study is HIV-negative pregnant women For qualitative data collection only investigators will also recruit male partners of these participants and PrEP counselors and health care workers 100 HIV-negative pregnant women will be recruited to participate in the pilot study A subset of these participants will participate in qualitative interviews Up to 20 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews
Procedures methods 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods Investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in oral PrEP will be referred to government PrEP services
Participants The primary population to be recruited for this study is HIV-negative pregnant women For qualitative data collection only investigators will also recruit male partners of these participants and PrEP counselors and health care workers 100 HIV-negative pregnant women will be recruited to participate in the pilot study A subset of these participants will participate in qualitative interviews Up to 20 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews
Procedures methods 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods Investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in oral PrEP will be referred to government PrEP services
Detailed Description:
Study design
This is a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods Investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in oral PrEP will be referred to government PrEP services
Study intervention intervention arm
The study intervention My Choice for HIV Prevention MyChoice is a counselor-delivered shared decision-making approach for pregnant women considering PrEP The intervention counseling will be delivered by trained study staff with a background in psychosocial counseling The intervention consists of counseling facilitated by a SDM tool The womans partner may be present depending on her preference It begins with a review of HIV risk in pregnancybreastfeeding including discussion of population-specific risk factors which may apply to the participant After understanding participant HIV risk and desire for HIV protection the counselor presents HIV prevention options including oral PrEP and internal and external condoms discussing attributes and potential advantages and disadvantages of each method This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant product attributes and personal and interpersonal implications of each method The counselor reviews information about these valued features for each offered method This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred methods The participant may defer or decline the decision and may request a follow-up counseling visit to take more time to consider her preference or return with a partner or other supporter If and when a decision is made the counselor provides post-decision counseling including adherence counseling and disclosure counseling if desired
Standard of care control arm
Participants randomized to the control arm will PrEP counseling as based on the current standard of care SOC The SOC counseling will be delivered by a trained study staff member The SOC counselor PrEP counseling according to national guidelinesPer current guidelines the SOC counseling may include the following elements An HIV risk assessment according to PrEP eligibility criteria discussion of a combination prevention approach PrEP and condoms and risk reduction strategies The women will receive comprehensive education on both the advantages and limitations of PrEP including guidance on managing potential side effects Subsequently the counselor will assess the womans eligibility willingness and readiness to start using PrEP
Participants choosing oral PrEP during the counselling session in either intervention or comparison arm will receive an assisted referral to government PrEP services at the study site to initiate their selected PrEP method per national guidelines Initiation of oral PrEP ie receipt of prescription will be confirmed through clinic or pharmacy records as well as information on reasons for non-initiation if applicable
Follow-up
Participants will complete follow-up visits at month 1 month 2 and month 3 Study visits will be scheduled to align with antenatal care ANCpharmacy visits whenever possible to minimize the number of trips needed at the clinic
Interviewer-administered questionnaires will be completed at the month 1 and month 3 follow-up visits Questionnaires will assess study outcomes and associated social and behavioural measures to contextualize understanding of primary study outcomes A subset of participants will complete in-depth qualitative interviews at month 1 Interviews will provide additional understanding of participant experiences with the intervention and experience using PrEP if applicable
At each follow-up visit women who have chosen oral PrEP will undergo adherence assessment through self-report and pill counts Furthermore investigators will collect dried blood spots DBS at month 2 to assess adherence among all oral PrEP users see below
Biological specimen collection and testing
To assess quantify drug concentrations to assess PrEP adherence among participants taking up oral PrEP a participant blood specimen will be collected via venipuncture at the for applicable participants those using oral PrEP This specimen will be used to create a dried blood spot DBS specimen at the local designated laboratory prior to storage and shipment to the reference pharmacology laboratory for testing
All samples will be obtained from study participants by trained study staff according to approved standard operating procedures All samples will be processed according to the assay manufacturers specifications Specimens will be transported processed and temporarily housed at UNC Project Malawi UNCPM Lilongwe Malawi and shipped to University of North Carolina UNC Chapel Hill for analysis All laboratory testing will be performed by trained staff using standard operating procedures and according to specific assay manufacturers specifications
This is a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods Investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in oral PrEP will be referred to government PrEP services
Study intervention intervention arm
The study intervention My Choice for HIV Prevention MyChoice is a counselor-delivered shared decision-making approach for pregnant women considering PrEP The intervention counseling will be delivered by trained study staff with a background in psychosocial counseling The intervention consists of counseling facilitated by a SDM tool The womans partner may be present depending on her preference It begins with a review of HIV risk in pregnancybreastfeeding including discussion of population-specific risk factors which may apply to the participant After understanding participant HIV risk and desire for HIV protection the counselor presents HIV prevention options including oral PrEP and internal and external condoms discussing attributes and potential advantages and disadvantages of each method This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant product attributes and personal and interpersonal implications of each method The counselor reviews information about these valued features for each offered method This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred methods The participant may defer or decline the decision and may request a follow-up counseling visit to take more time to consider her preference or return with a partner or other supporter If and when a decision is made the counselor provides post-decision counseling including adherence counseling and disclosure counseling if desired
Standard of care control arm
Participants randomized to the control arm will PrEP counseling as based on the current standard of care SOC The SOC counseling will be delivered by a trained study staff member The SOC counselor PrEP counseling according to national guidelinesPer current guidelines the SOC counseling may include the following elements An HIV risk assessment according to PrEP eligibility criteria discussion of a combination prevention approach PrEP and condoms and risk reduction strategies The women will receive comprehensive education on both the advantages and limitations of PrEP including guidance on managing potential side effects Subsequently the counselor will assess the womans eligibility willingness and readiness to start using PrEP
Participants choosing oral PrEP during the counselling session in either intervention or comparison arm will receive an assisted referral to government PrEP services at the study site to initiate their selected PrEP method per national guidelines Initiation of oral PrEP ie receipt of prescription will be confirmed through clinic or pharmacy records as well as information on reasons for non-initiation if applicable
Follow-up
Participants will complete follow-up visits at month 1 month 2 and month 3 Study visits will be scheduled to align with antenatal care ANCpharmacy visits whenever possible to minimize the number of trips needed at the clinic
Interviewer-administered questionnaires will be completed at the month 1 and month 3 follow-up visits Questionnaires will assess study outcomes and associated social and behavioural measures to contextualize understanding of primary study outcomes A subset of participants will complete in-depth qualitative interviews at month 1 Interviews will provide additional understanding of participant experiences with the intervention and experience using PrEP if applicable
At each follow-up visit women who have chosen oral PrEP will undergo adherence assessment through self-report and pill counts Furthermore investigators will collect dried blood spots DBS at month 2 to assess adherence among all oral PrEP users see below
Biological specimen collection and testing
To assess quantify drug concentrations to assess PrEP adherence among participants taking up oral PrEP a participant blood specimen will be collected via venipuncture at the for applicable participants those using oral PrEP This specimen will be used to create a dried blood spot DBS specimen at the local designated laboratory prior to storage and shipment to the reference pharmacology laboratory for testing
All samples will be obtained from study participants by trained study staff according to approved standard operating procedures All samples will be processed according to the assay manufacturers specifications Specimens will be transported processed and temporarily housed at UNC Project Malawi UNCPM Lilongwe Malawi and shipped to University of North Carolina UNC Chapel Hill for analysis All laboratory testing will be performed by trained staff using standard operating procedures and according to specific assay manufacturers specifications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01MH121186 | NIH | None | httpsreporternihgovquickSearchK01MH121186 |