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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH116806-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Brown University | OTHER |
| Ministry of Health, Malawi | OTHER_GOV |
| University of Zimbabwe |
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In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce mother-to-child HIV transmission. However, loss to HIV care after delivery has emerged as an important threat to the hoped-for impact of Option B+. Evidence suggests that one important contributor to postpartum loss to HIV care is perinatal depression (PND). In non-pregnant HIV-infected populations, depression has been linked to poor ART adherence, reduced engagement in care, and ultimately worse HIV clinical outcomes. Thus, interventions that integrate PND treatment with targeted support for HIV care retention are critical to the success of Option B+.
The Friendship Bench is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings, but has not been adapted to address PND, or enhanced to support engagement in HIV care. The Friendship Bench offers an ideal framework for integrating retention support into a proven depression treatment model. Our long-term goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve engagement in HIV care. The objective of this proposal is to lay the groundwork for an effectiveness trial by adapting the Friendship Bench intervention to address PND and support engagement in care among perinatal HIV-infected women and assessing the feasibility, acceptability, and fidelity of the adapted intervention in Lilongwe, Malawi. In-depth perspectives on PND and its role in engagement in care will be gathered from HIV-infected women with PND, healthcare providers, clinic directors, and Ministry of Health officials using qualitative interviews and focus groups. This formative research will be used to develop an intervention protocol adapted to the unique needs of HIV-infected women during the perinatal period (Adapted Friendship Bench) and further enhanced to support engagement in HIV care (Enhanced Friendship Bench). The Adapted and Enhanced Friendship Bench interventions will be compared to enhanced standard care in a 3-arm pilot study. Feasibility, acceptability, and fidelity will be assessed at 6 months postpartum, along with the interventions' preliminary effectiveness across several mental health and engagement in HIV care measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Friendship Bench (EFB) | Experimental | 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) | Active Comparator | 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. |
|
| Adapted Friendship Bench (AFB) | Experimental | 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 Adapted Friendship Bench intervention from date of enrollment through 6 months post-partum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Friendship Bench | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility- Number of Participants Enrolled in Each Arm | 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. | Study enrollment period of approximately 16 months |
| Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum | The proportion of enrolled study participants that remain in their assigned study arm at 6-months post-partum. | 6-months post-partum |
| Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in | 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. | 6 months post-partum |
| Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items | 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. | Entire study period (Study baseline through 6 months post-partum) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20) | 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). |
Women
Inclusion criteria:
Exclusion criteria:
The investigators are recruiting pregnant women with perinatal depression
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pence, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mitundu Health Center | Lilongwe | Lilogwe | Malawi | |||
| Lumbadzi Health Center |
The investigators do not intend to share individual participant data (IPD) with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-pilot |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2022 |
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| OTHER |
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| Enhanced Standard Care (Control) | Other | 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. |
|
| Adapted Friendship Bench | Behavioral | 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. |
|
| 6 months post-partum |
| 6 months post-partum |
| Proportion of Women Retained in HIV Care | The proportion of women who attended at least 1 HIV care appointment within 30-days prior to the 6-month interview. | 6 months post-partum |
| Proportion of Women Virally Suppressed | The proportion of women in each arm with an HIV viral load of <1,000 copies/mL | 6 months post partum |
| The Proportion of Women Whose Infants Received an HIV Viral Load Test | 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 | 6 months post partum |
| Lilongwe |
| Malawi |
| Nathenje Health Center | Lilongwe | Malawi |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Pilot Trial |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | Enhanced Friendship Bench (EFB) | 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Feasibility- Number of Participants Enrolled in Each Arm | 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. | Posted | Count of Participants | Participants | Study enrollment period of approximately 16 months |
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| Primary | Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum | The proportion of enrolled study participants that remain in their assigned study arm at 6-months post-partum. | Posted | Number | proportion of participants | 6-months post-partum |
| |||||||||||||||||||||||||||||||||||
| Primary | Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in | 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. | 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. | Posted | Number | proportion of EFB participants | 6 months post-partum |
| ||||||||||||||||||||||||||||||||||
| Primary | Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items | 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. | 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. | Posted | Number | proportion of sessions meeting threshold | Entire study period (Study baseline through 6 months post-partum) | Intervention Sessions | Intervention Sessions |
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| Secondary | Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression | 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. | 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). | Posted | Number | proportion of participants | 6 months post-partum |
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| Other Pre-specified | Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20) | 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). | 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). | Posted | Number | proportion of participants | 6 months post-partum |
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| Other Pre-specified | Proportion of Women Retained in HIV Care | The proportion of women who attended at least 1 HIV care appointment within 30-days prior to the 6-month interview. | 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). | Posted | Number | proportion of participants | 6 months post-partum |
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| Other Pre-specified | Proportion of Women Virally Suppressed | The proportion of women in each arm with an HIV viral load of <1,000 copies/mL | 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. | Posted | Number | proportion of participants | 6 months post partum |
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| Other Pre-specified | The Proportion of Women Whose Infants Received an HIV Viral Load Test | 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 | 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. | Posted | Number | proportion of participants | 6 months post partum |
|
Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 5 | 1 | 5 | 0 | 5 |
| EG001 | Enhanced Friendship Bench (EFB) | 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. | 0 | 43 | 4 | 43 | 0 | 43 |
| EG002 | 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. 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. | 0 | 44 | 5 | 44 | 0 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infant Death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Wells Pence, PhD | University of North Carolina at Chapel Hill | +1 919-966-7446 | bpence@unc.edu |
| Jun 12, 2023 |
| Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Screening | Nov 24, 2020 | Aug 10, 2023 | ICF_004.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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. |
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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.
| OG002 | 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. |
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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. |
| OG002 | 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. |
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| OG002 | 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. |
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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. |
|
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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.
|
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| OG002 | 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. |
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