Trial Outcomes & Findings for An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women (NCT NCT04330989)
NCT ID: NCT04330989
Last Updated: 2023-01-11
Results Overview
The primary outcome measure is retention in care with HIV viral suppression, defined as \<40 copies/mL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
6 months following study enrollment
Results posted on
2023-01-11
Participant Flow
Participant milestones
| Measure |
Group 1a: Integrated Next Step Counseling (iNSC) and Adherence Supporter Training
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising Integrated Next Step Counseling (iNSC) and adherence supporter training for antiretroviral therapy (ART).
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising Integrated Next Step Counseling (iNSC) and adherence supporter training for HIV pre-exposure prophylaxis (PrEP).
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
100
|
100
|
|
Overall Study
Liveborn Infants During Study
|
43
|
46
|
87
|
90
|
|
Overall Study
COMPLETED
|
41
|
43
|
88
|
83
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
12
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
Baseline characteristics by cohort
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 Participants
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
27 years
n=7 Participants
|
25 years
n=5 Participants
|
24 years
n=4 Participants
|
25 years
n=21 Participants
|
|
Age, Customized
< 20 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Customized
20-24 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Age, Customized
25-29 years
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Age, Customized
30-34 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Age, Customized
35+ years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Malawi
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Education
Primary school completed
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Education
Did not complete primary school
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Gestational age at enrollment, continuous
|
26 weeks
n=5 Participants
|
24 weeks
n=7 Participants
|
28 weeks
n=5 Participants
|
26 weeks
n=4 Participants
|
26 weeks
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months following study enrollmentPopulation: Pregnant women living with HIV (Groups 1a and 1b only)
The primary outcome measure is retention in care with HIV viral suppression, defined as \<40 copies/mL.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)
|
35 Participants
|
30 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 months following study enrollmentPopulation: Pregnant women who are HIV-negative (Groups 2a and 2b only)
The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 Participants
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)
|
—
|
—
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentPopulation: Population comprises those in Groups 1a and 2a who attended their six month study visit and had a recorded counseling session for the visit
Extent to which Integrated Next Step Counseling (iNSC) was delivered as intended for each counseling session, obtained by audits of recorded counseling sessions. Counseling sessions were assessed according 50 evaluable actions. Each of these could be scored 0 (not done), 1 (partially done), and 2 (done well). These were aggregated into an overall score for fidelity, with an overall score range of 0-100. Higher scores represented greater counselor adherence to the iNSC framework.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=39 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=86 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session
|
89.3 score on a scale
Interval 72.9 to 92.9
|
—
|
80.4 score on a scale
Interval 70.7 to 86.4
|
—
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentPopulation: Satisfaction with the intervention measured only in those randomized to receive the intervention (Groups 1a and 2a)
Satisfaction with overall intervention. Participants were asked: "How satisfied would you say you are with the program overall (both the iNSC and the Adherence Supporter)?" The five possible answers are shown below.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Very satisfied
|
42 Participants
|
—
|
89 Participants
|
—
|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Somewhat satisfied
|
1 Participants
|
—
|
2 Participants
|
—
|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Neither satisfied nor unsatisfied
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Somewhat unsatisfied
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Very unsatisfied
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Reported Level of Satisfaction by Participants for the Study Intervention
Missing
|
8 Participants
|
—
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentPopulation: Pregnant women living with HIV (Groups 1a and 1b only)
The secondary outcome measure is retention in care with HIV viral suppression, defined as \<1000 copies/mL.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)
|
37 Participants
|
35 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentPopulation: Pregnant women living with HIV (Groups 1a and 1b only)
The secondary outcome measure is retention in care with self-reported ART adherence \>95% over the last 30 days. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)
|
37 Participants
|
32 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentPopulation: Pregnant women who are HIV-negative (Groups 2a and 2b only)
The secondary outcome is retention in care with \>95% adherence to PrEP over the last 30 days by participant self-report. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 Participants
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)
|
—
|
—
|
45 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 3 months following study enrollmentNewly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 Participants
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Reporting Social Harms
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months following study enrollmentNewly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made.
Outcome measures
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 Participants
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 Participants
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 Participants
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 Participants
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Number of Participants Reporting Social Harms
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Group 1a: iNSC and Adherence Supporter Training
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1b: Standard of Care
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2a: iNSC and Adherence Supporter Training
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2b: Standard of Care
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 participants at risk
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 participants at risk
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 participants at risk
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 participants at risk
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Fetal demise (stillbirths and spontaneous abortions)
|
7.8%
4/51 • Number of events 4 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
0.00%
0/49 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
8.0%
8/100 • Number of events 8 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
3.0%
3/100 • Number of events 3 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.00%
0/51 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
4.1%
2/49 • Number of events 2 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
3.0%
3/100 • Number of events 3 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
2.0%
2/100 • Number of events 2 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
|
Infections and infestations
Incident HIV infection (maternal)
|
0.00%
0/51 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
0.00%
0/49 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
0.00%
0/100 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
1.0%
1/100 • Number of events 1 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
Other adverse events
| Measure |
Group 1a: iNSC and Adherence Supporter Training
n=51 participants at risk
HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 1b: Standard of Care
n=49 participants at risk
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
|
Group 2a: iNSC and Adherence Supporter Training
n=100 participants at risk
HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
|
Group 2b: Standard of Care
n=100 participants at risk
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth
|
2.0%
1/51 • Number of events 1 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
14.3%
7/49 • Number of events 7 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
5.0%
5/100 • Number of events 5 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
6.0%
6/100 • Number of events 6 • From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place