Trial Outcomes & Findings for Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe (NCT NCT04143009)
NCT ID: NCT04143009
Last Updated: 2023-08-14
Results Overview
This measure of feasibility will be assessed as the number of women enrolled in each arm out of the desired total sample size of 92 women during the 16 month recruitment period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Study enrollment period of approximately 16 months
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Adapted Friendship Bench (AFB)
5 women seeking antenatal care (ANC) service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Adapted Friendship Bench (AFB): AFB will include the following: integrating problem solving therapy- based and antiretroviral therapy (ART) adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.
|
Enhanced Friendship Bench (EFB)
43 women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Enhanced Friendship Bench: EFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions, and retention strategies to support engagement in care for HIV-infected women with perinatal depression (PND). This intervention will include 4 individual prenatal and 2 group postnatal counseling sessions. To provide additional social support, one support session will be added, at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will conduct up to 6 home visits. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.
|
Enhanced Standard Care (ESC)
44 women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
Enhanced Standard Care \[ESC (Control)\]: Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.
|
|---|---|---|---|
|
Pre-pilot
STARTED
|
5
|
3
|
4
|
|
Pre-pilot
COMPLETED
|
5
|
3
|
4
|
|
Pre-pilot
NOT COMPLETED
|
0
|
0
|
0
|
|
Pilot Trial
STARTED
|
0
|
40
|
40
|
|
Pilot Trial
COMPLETED
|
0
|
39
|
39
|
|
Pilot Trial
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Adapted Friendship Bench (AFB)
5 women seeking antenatal care (ANC) service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Adapted Friendship Bench (AFB): AFB will include the following: integrating problem solving therapy- based and antiretroviral therapy (ART) adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.
|
Enhanced Friendship Bench (EFB)
43 women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Enhanced Friendship Bench: EFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions, and retention strategies to support engagement in care for HIV-infected women with perinatal depression (PND). This intervention will include 4 individual prenatal and 2 group postnatal counseling sessions. To provide additional social support, one support session will be added, at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will conduct up to 6 home visits. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.
|
Enhanced Standard Care (ESC)
44 women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
Enhanced Standard Care \[ESC (Control)\]: Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.
|
|---|---|---|---|
|
Pilot Trial
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Adapted Friendship Bench (AFB): AFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.
|
Enhanced Friendship Bench (EFB)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Enhanced Friendship Bench: EFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions, and retention strategies to support engagement in care for HIV-infected women with PND. This intervention will include 4 individual prenatal and 2 group postnatal counseling sessions. To provide additional social support, one support session will be added, at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will conduct up to 6 home visits. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.
|
Enhanced Standard Care (ESC)
n=44 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
Enhanced Standard Care (Control): Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 5.6 • n=43 Participants
|
28.1 years
STANDARD_DEVIATION 5.9 • n=44 Participants
|
28.3 years
STANDARD_DEVIATION 6.0 • n=92 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
43 Participants
n=43 Participants
|
44 Participants
n=44 Participants
|
92 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Malawi
|
5 Participants
n=5 Participants
|
43 Participants
n=43 Participants
|
44 Participants
n=44 Participants
|
92 Participants
n=92 Participants
|
PRIMARY outcome
Timeframe: Study enrollment period of approximately 16 monthsThis measure of feasibility will be assessed as the number of women enrolled in each arm out of the desired total sample size of 92 women during the 16 month recruitment period.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=44 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Intervention Feasibility- Number of Participants Enrolled in Each Arm
|
5 Participants
|
43 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: 6-months post-partumThe proportion of enrolled study participants that remain in their assigned study arm at 6-months post-partum.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=44 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum
|
1 proportion of participants
|
0.98 proportion of participants
|
0.98 proportion of participants
|
PRIMARY outcome
Timeframe: 6 months post-partumPopulation: This outcome measures acceptability of the EFB intervention, and as such, acceptability measures were only collected among a subset of EFB participants (n = 15) and does not apply to the AFB or ESC participants.
The proportion of women in the intervention arm (EFB) that were either "satisfied" or "highly satisfied" with the intervention as reported in the 6-month follow-up survey.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=15 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in
|
—
|
1 proportion of EFB participants
|
—
|
PRIMARY outcome
Timeframe: Entire study period (Study baseline through 6 months post-partum)Population: Fidelity to the intervention was assessed at the session level for the EFB arm. Fidelity was not assessed in the AFB arm as this arm was not included in study period 2 (Pilot Trial). Fidelity was not assessed in the ESC arm because the ESC arm did not receive the intervention. A total of 82 out of 208 completed sessions were assessed for fidelity among a randomly selected subset of 27 participants.
Fidelity will be assessed by members of the Friendship Bench team (DHO or study psychiatrist), by using a checklist of intervention characteristics either during direct monitoring or using audio recording of up to 3 randomly chosen counseling sessions. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=82 Intervention Sessions
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items
|
—
|
0.83 proportion of sessions meeting threshold
|
—
|
SECONDARY outcome
Timeframe: 6 months post-partumPopulation: The analysis population for each arm consists of all the participants who completed the 6-month interview. In the AFB arm, 5 of 5 participants completed the interview. In the EFB arm, 42 of 43 participants completed the 6 month interview (1 participant lost to follow up). In the ESC arm, 43 of 44 participants completed the 6 month interview (1 participant lost to follow up).
The investigator will assess a combined outcome at 6 months of whether a woman was retained in HIV care (defined as attending an HIV care appointment within the 30 days prior to the 6-month interview) and had ≥50% improvement in the Self-Reporting Questionnaire-20 (SRQ-20) score from baseline. The SRQ-20 was developed by the World Health Organization and has scores ranging from 0 to 20 and higher scores indicating a greater level of depression. Scores greater than or equal to 8 are typically considered indicative of a common mental disorder (CMD). This measure will capture the proportion of enrolled women with the composite outcome of interest described above.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=42 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression
|
0.20 proportion of participants
|
0.40 proportion of participants
|
0.14 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-partumPopulation: The analysis population for each arm consists of all the participants who completed the 6-month interview. In the AFB arm, 5 of 5 participants completed the interview. In the EFB arm, 42 of 43 participants completed the 6 month interview (1 participant lost to follow up). In the ESC arm, 43 of 44 participants completed the 6 month interview (1 participant lost to follow up).
The proportion of women in each arm that score greater than or equal to 8 on the Self-Reporting Questionnaire-20 at a study visit approximately 6-months post-partum. The SRQ-20 was developed by the World Health Organization and has scores ranging from 0 to 20 and higher scores indicating a greater level of depression. Scores greater than or equal to 8 are typically considered indicative of a common mental disorder (CMD).
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=42 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20)
|
0.60 proportion of participants
|
0.21 proportion of participants
|
0.30 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-partumPopulation: The analysis population for each arm consists of all the participants who completed the 6-month interview. In the AFB arm, 5 of 5 participants completed the interview. In the EFB arm, 42 of 43 participants completed the 6 month interview (1 participant lost to follow up). In the ESC arm, 43 of 44 participants completed the 6 month interview (1 participant lost to follow up).
The proportion of women who attended at least 1 HIV care appointment within 30-days prior to the 6-month interview.
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=42 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=43 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Proportion of Women Retained in HIV Care
|
0.20 proportion of participants
|
0.50 proportion of participants
|
0.26 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post partumPopulation: The analysis population for each arm consists of all the participants who had a viral load sample collected in the 6 month interview study window. In the AFB arm 5/5 participants had a viral load sample collected. In the EFB arm 30/43 women had a viral load sample collected. In the ESC arm, 32/44 women had a sample viral load collected.
The proportion of women in each arm with an HIV viral load of \<1,000 copies/mL
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=5 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=30 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=32 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
Proportion of Women Virally Suppressed
|
0.8 proportion of participants
|
0.93 proportion of participants
|
0.91 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post partumPopulation: The AFB arm includes 4/5 participants included in the analysis population as there was 1 infant death in the AFB arm. The EFB arm includes 38/43 participants included in the analysis population as there were 3 infant deaths, 1 miscarriage, and 1 woman lost to follow up. The ESC arm includes 38/44 participants included in the analysis population as there were 2 infant deaths, 2 still births, 1 miscarriage, and 1 woman lost to follow up.
The proportion of women in each arm whose infants had received an HIV viral load test by the time of a study visit approximately 6-months post-partum
Outcome measures
| Measure |
Adapted Friendship Bench (AFB)
n=4 Participants
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Friendship Bench (EFB)
n=38 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
|
Enhanced Standard Care (ESC)
n=38 Participants
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
|
|---|---|---|---|
|
The Proportion of Women Whose Infants Received an HIV Viral Load Test
|
1 proportion of participants
|
0.95 proportion of participants
|
0.95 proportion of participants
|
Adverse Events
Adapted Friendship Bench (AFB)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Friendship Bench (EFB)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Standard Care (ESC)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapted Friendship Bench (AFB)
n=5 participants at risk
Women seeking ANC service at a public health center in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Adapted Friendship Bench (AFB): AFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.
|
Enhanced Friendship Bench (EFB)
n=43 participants at risk
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Enhanced Friendship Bench: EFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions, and retention strategies to support engagement in care for HIV-infected women with PND. This intervention will include 4 individual prenatal and 2 group postnatal counseling sessions. To provide additional social support, one support session will be added, at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will conduct up to 6 home visits. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.
|
Enhanced Standard Care (ESC)
n=44 participants at risk
Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
Enhanced Standard Care (Control): Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Infant Death
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
7.0%
3/43 • Number of events 3 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/5 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
2.3%
1/43 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/5 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
0.00%
0/43 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
|
Other adverse events
Adverse event data not reported
Additional Information
Brian Wells Pence, PhD
University of North Carolina at Chapel Hill
Phone: +1 919-966-7446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place