Trial Outcomes & Findings for Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi (NCT NCT06394323)

Last Updated: 2025-12-24

Results Overview

Intervention acceptability was defined as the extent to which participants perceived the intervention to be agreeable, palatable, or satisfactory. Acceptability was assessed through participant self-report using a validated 4-item scale (AIM). This scale measures how agreeable and satisfactory women find the intervention (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 5="Completely Agree"). For each participant at each timepoint, a mean AIM scale score was calculated ranging from 1 to 5. Higher scores indicate greater acceptability. Individuals' mean AIM scale scores were averaged at each timepoint, and a 95% confidence interval around the mean of means was calculated using the common standard error.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

enrollment visit (month 0), month 2 follow up visit

Results posted on

2025-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	My Choice for HIV Prevention (MyChoice) The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy and the postpartum period including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 (including product attributes and personal and interpersonal implications of each method). The counselor reviews information about the participant's valued features for each method offered. 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 method(s).	Standard of Care (SOC) Control Arm Participants randomized to the control arm receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling is delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor assesses each participant's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Overall Study STARTED	50	50	20	12
Overall Study Month 2	46	42	20	12
Overall Study COMPLETED	46	43	20	12
Overall Study NOT COMPLETED	4	7	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	My Choice for HIV Prevention (MyChoice) The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy and the postpartum period including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 (including product attributes and personal and interpersonal implications of each method). The counselor reviews information about the participant's valued features for each method offered. 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 method(s).	Standard of Care (SOC) Control Arm Participants randomized to the control arm receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling is delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor assesses each participant's eligibility, willingness, and readiness to start using daily oral PrEP.
Overall Study Death	0	1
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	My Choice for HIV Prevention (MyChoice) n=50 Participants The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy and the postpartum period including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 (including product attributes and personal and interpersonal implications of each method). The counselor reviews information about the participant's valued features for each method offered. 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 method(s).	Standard of Care (SOC) Control Arm n=50 Participants Participants randomized to the control arm receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling is delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor assesses each participant's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews n=20 Participants Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews n=12 Participants Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=20 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=12 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=132 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	50 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	20 Participants n=20 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	12 Participants n=12 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	132 Participants n=132 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.
Age, Categorical >=65 years	0 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=50 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=20 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=12 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.	0 Participants n=132 Participants • Specific age data were collected for all Arms except the Male Partners but based on Inclusion criteria and counselor interactions, all Male Partners were \>/= 18 and \</= 65 years of age.
Age, Continuous	24 years n=50 Participants • Age was not collected for Male Partners.	24 years n=50 Participants • Age was not collected for Male Partners.	—	35 years n=12 Participants • Age was not collected for Male Partners.	24 years n=112 Participants • Age was not collected for Male Partners.
Sex: Female, Male Female	50 Participants n=50 Participants	50 Participants n=50 Participants	0 Participants n=20 Participants	12 Participants n=12 Participants	112 Participants n=132 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=50 Participants	20 Participants n=20 Participants	0 Participants n=12 Participants	20 Participants n=132 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=50 Participants	50 Participants n=50 Participants	20 Participants n=20 Participants	12 Participants n=12 Participants	132 Participants n=132 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Asian	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Black or African American	50 Participants n=50 Participants	50 Participants n=50 Participants	20 Participants n=20 Participants	12 Participants n=12 Participants	132 Participants n=132 Participants
Race (NIH/OMB) White	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) More than one race	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=20 Participants	0 Participants n=12 Participants	0 Participants n=132 Participants
Region of Enrollment Malawi	50 Participants n=50 Participants	50 Participants n=50 Participants	20 Participants n=20 Participants	12 Participants n=12 Participants	132 Participants n=132 Participants

PRIMARY outcome

Timeframe: enrollment visit (month 0), month 2 follow up visit

Population: Only participants that received the MyChoice intervention and had one or more completed items of the AIM scale were included. Participants in the Standard of Care (SOC) Control Arm, Male Partner In-Depth Interviews, and Clinician and Counselor In-Depth Interviews were not asked to complete these items.

Outcome measures

Outcome measures
Measure	My Choice for HIV Prevention (MyChoice) n=50 Participants The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 method(s).	Standard of Care (SOC) Control Arm Participants randomized to the control arm will receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling will be delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants will receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Mean Acceptability of Intervention (AIM) Scale Score Enrollment (Month 0)	4.65 score on a scale Interval 4.52 to 4.77	—	—	—
Mean Acceptability of Intervention (AIM) Scale Score Month 2	4.52 score on a scale Interval 4.39 to 4.66	—	—	—

PRIMARY outcome

Timeframe: enrollment visit (month 0), month 2 follow up visit

Population: Only participants that received the MyChoice intervention and had one or more completed items of the IAM scale were included. Participants in the Standard of Care (SOC) Control Arm, Male Partner In-Depth Interviews, and Clinician and Counselor In-Depth Interviews were not asked to complete these items.

Intervention appropriateness was defined as the perceived relevance and usefulness of the intervention to support decision making about HIV prevention methods. Appropriateness was assessed through self-report using a validated 4-item scale (IAM) to measure women's perceptions of its relevance and usefulness (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 5="Completely Agree"). For each participant at each timepoint, a mean IAM scale score was calculated ranging from 1 to 5. Higher scores indicate greater appropriateness. Individuals' mean IAM scale scores were averaged at each timepoint, and a 95% confidence interval around the mean of means was calculated using the common standard error.

Outcome measures

Outcome measures
Measure	My Choice for HIV Prevention (MyChoice) n=50 Participants The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 method(s).	Standard of Care (SOC) Control Arm Participants randomized to the control arm will receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling will be delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants will receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Mean Intervention Appropriateness Measure (IAM) Scale Score Enrollment (Month 0)	4.59 score on a scale Interval 4.47 to 4.71	—	—	—
Mean Intervention Appropriateness Measure (IAM) Scale Score Month 2	4.46 score on a scale Interval 4.32 to 4.61	—	—	—

PRIMARY outcome

Timeframe: enrollment visit (month 0)

Population: Only participants that received the MyChoice intervention and had one or more completed items of the FIM scale were included. Participants in the Standard of Care (SOC) Control Arm, Male Partner In-Depth Interviews, and Clinician and Counselor In-Depth Interviews were not asked to complete these items.

Intervention feasibility was defined as extent to which the intervention is perceived to be feasible or practical. Feasibility was assessed through self-report using a validated 4-item scale (FIM) to measure women's perceptions of its practicability and ease of use (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 1="Completely Agree"). For each participant at month 0, a mean FIM scale score was calculated ranging from 1 to 5. Higher scores indicate greater feasibility. Individuals' mean FIM scale scores were averaged, and a 95% confidence interval around the mean of means was calculated using the common standard error.

Outcome measures

Outcome measures
Measure	My Choice for HIV Prevention (MyChoice) n=50 Participants The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 method(s).	Standard of Care (SOC) Control Arm Participants randomized to the control arm will receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling will be delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants will receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Mean Feasibility Intervention Measure (FIM) Scale Score	4.53 score on a scale Interval 4.4 to 4.65	—	—	—

SECONDARY outcome

Timeframe: enrollment visit (month 0)

Population: Participants that received the MyChoice intervention or SOC at month 0 were included if they had at least one non-missing item on the 16-item DCS. Participants in the Male Partner In-Depth Interviews and Clinician and Counselor In-Depth Interviews arms were not asked to complete these items.

A validated scale (DCS) was utilized to assess participants' perceptions decisional conflict regarding the decision whether to use PrEP following receipt of MyChoice or SOC counseling. The 16 items in the scale assess these perceptions by asking participants to rate statements regarding their perceived level of uncertainty, satisfaction, clarity of personal values, and support for decision-making. Responses are rated on a 5-point Likert scale ranging from 0="Strongly agree" to 4="Strongly Disagree". DCS scores range from 0 to 100 points (mean item rating multiplied by 25), with higher scores indicating a higher level of decisional conflict. At month 0 after the intervention, individuals' mean DCS scores were averaged, and a 95% confidence interval around the mean of means was calculated using the common standard error. Only participants that had one or more completed items of the DCS were included.

Outcome measures

Outcome measures
Measure	My Choice for HIV Prevention (MyChoice) n=50 Participants The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 method(s).	Standard of Care (SOC) Control Arm n=50 Participants Participants randomized to the control arm will receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling will be delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants will receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Mean Decisional Conflict Scale (DCS) Score	14.8 score on a scale Interval 10.3 to 19.3	18.3 score on a scale Interval 15.3 to 21.3	—	—

Adverse Events

My Choice for HIV Prevention (MyChoice)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care (SOC) Control Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Male Partner In-Depth Interviews

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinician and Counselor In-Depth Interviews

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	My Choice for HIV Prevention (MyChoice) n=50 participants at risk The MyChoice intervention consists of pre-exposure prophylaxis (PrEP) shared decision-making counseling delivered by a trained counselor, administered at month 0 following randomization to this arm. The MyChoice intervention begins with a review of HIV risk in pregnancy and the postpartum period including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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 (including product attributes and personal and interpersonal implications of each method). The counselor reviews information about the participant's valued features for each method offered. 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 method(s).	Standard of Care (SOC) Control Arm n=50 participants at risk Participants randomized to the control arm receive pre-exposure prophylaxis (PrEP) counseling based on the current standard of care (SOC) at month 0 after randomization to this arm. The SOC counseling is delivered by a trained study staff member. The SOC counselor delivers PrEP counseling according to national guidelines. Control arm participants receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor assesses each participant's eligibility, willingness, and readiness to start using daily oral PrEP.	Male Partner In-Depth Interviews n=20 participants at risk Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).	Clinician and Counselor In-Depth Interviews n=12 participants at risk Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/50 • From completion of the baseline visit through the last completed study visit, up to 3 months. The severity of adverse events (AEs) was graded using the National Institute of Health's Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.	2.0% 1/50 • Number of events 1 • From completion of the baseline visit through the last completed study visit, up to 3 months. The severity of adverse events (AEs) was graded using the National Institute of Health's Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.	0.00% 0/20 • From completion of the baseline visit through the last completed study visit, up to 3 months. The severity of adverse events (AEs) was graded using the National Institute of Health's Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.	0.00% 0/12 • From completion of the baseline visit through the last completed study visit, up to 3 months. The severity of adverse events (AEs) was graded using the National Institute of Health's Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.

Other adverse events

Adverse event data not reported

Additional Information

Lauren Hill, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-5771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place