Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-19
Brief Title:
Supporting Oral and Long-acting PrEP 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 22325 - Supporting Oral and Long-acting Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe Malawi a Feasibility Pilot Study
Status:
NOT_YET_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 Pre-exposure prophylaxis 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 The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period Investigators will recruit 50 women to participate in the feasibility pilot study A subset of these participants will participate in qualitative interviews Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews
Procedures methods Investigators propose a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP Long-acting injectable cabotegravir CAB-LA and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods In both studies investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in either PrEP method 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 The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period Investigators will recruit 50 women to participate in the feasibility pilot study A subset of these participants will participate in qualitative interviews Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews
Procedures methods Investigators propose a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP Long-acting injectable cabotegravir CAB-LA and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods In both studies investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in either PrEP method will be referred to government PrEP services
Detailed Description:
Study design
Investigators propose a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP CAB-LA and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods In both studies investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in either PrEP method will be referred to government PrEP services
Study intervention
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 CAB-LA daily 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
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 guidelines Per 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 Women choosing oral PrEP during the SOC counseling session will be referred to government services to initiate PrEP Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program
Participants will be randomly assigned 11 to one of two study arms intervention or comparison using permuted block randomization Participants will be blinded to their assignment but study staff will not
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 Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program No study drug will be administered Initiation of either PrEP method ie receipt of prescription or injection will be confirmed through clinic or pharmacy records as well as information on reasons for non-initiation if applicable
Investigators plan study follow-up visits at month 1 and month 2 following enrollment Interviewer-administered questionnaires will be completed at the month 1 follow-up and the final follow-up visit month 2 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
Investigators propose a pilot feasibility study of a shared decision making SDM intervention for pregnant women considering PrEP 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP CAB-LA and alternative HIV prevention methods condoms or standard of care counselling addressing the same prevention methods In both studies investigators will evaluate the feasibility acceptability and appropriateness of the intervention and associated study procedures Women expressing interest in either PrEP method will be referred to government PrEP services
Study intervention
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 CAB-LA daily 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
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 guidelines Per 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 Women choosing oral PrEP during the SOC counseling session will be referred to government services to initiate PrEP Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program
Participants will be randomly assigned 11 to one of two study arms intervention or comparison using permuted block randomization Participants will be blinded to their assignment but study staff will not
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 Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program No study drug will be administered Initiation of either PrEP method ie receipt of prescription or injection will be confirmed through clinic or pharmacy records as well as information on reasons for non-initiation if applicable
Investigators plan study follow-up visits at month 1 and month 2 following enrollment Interviewer-administered questionnaires will be completed at the month 1 follow-up and the final follow-up visit month 2 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
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 |
|---|---|---|---|
| P30AI050410 | NIH | None | httpsreporternihgovquickSearchP30AI050410 |