Depression, Human Immunodeficiency Virus
Conditions
Keywords
HIV, Medication adherence, PMTCT, Depression
Brief summary
The main aim was to conduct a pilot field test of a group-based depression and adherence counseling intervention with HIV-infected women in the perinatal period. Participants were HIV-infected women living in KwaZulu-Natal, South Africa.
Detailed description
The main aim of this study was to conduct a pilot field test of a group-based counseling intervention with HIV-infected women in the perinatal period as delivered by a lay counselor. The primary goal of the intervention was to reduce symptoms of perinatal depression and increase adherence to antiretroviral therapy among HIV-infected women during pregnancy and the postpartum period.
Interventions
A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women
Sponsors
Study design
Eligibility
Inclusion criteria
* Currently pregnant * HIV-infected and diagnosed with HIV during the index pregnancy * Meet criteria for a major depressive episode * Currently on antiretroviral therapy * Receiving antenatal care at PMMH Gateway clinic * Primary language English or isiZulu * Access to a phone and willing to give researchers permission to reach them via phone * Resident of Umlazi
Exclusion criteria
* Unable or unwilling to provide informed consent * Active untreated, major mental illness (untreated psychosis, bipolar disorder, dementia, or active suicidality) that would interfere with study participation * Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Antiretroviral Therapy Per Self-Report | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | Adherence to ART during the previous month was measured through a composite score developed by Lu et al. (2008). The composite score combines the scores of three items into a single self-reported adherence score; the three items assess medication use frequency, percentage of time that the medication was taken as prescribed, and a rating of one's ability to take prescribed medication. The percent item had 11 response categories (0, 10, 20…100%), whereas the frequency and ability items had six response categories that were assigned scores of 0, 20, 40, 60, 80, and 100, with 100 considered to be perfect adherence. |
| Adherence to Antiretroviral Therapy Per MEMS Caps | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | Objective ART adherence data were collected using the Medication Event Monitoring System (MEMS), which comprises a pill bottle with a digitized cap that measures and records when the bottle was opened each day. MEMS timepoints were defined as average MEMS use across the two-week period prior to each of the three assessment visits. |
| Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | The 10-item Edinburgh Postnatal Depression Scale (EPDS) was used to measure depressive symptoms at baseline, post-treatment, and three-month follow-up; higher scores indicate more severe depressive symptoms. The minimum possible score is 0, and maximum score is 30. A standard clinical cutoff of 13 on the EPDS was used to distinguish women with and without probable depression. |
| Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | Current and past major depressive disorder was measured using the 17-item Major Depressive Episode Module of the Mini International Neuropsychiatric Interview (MINI). If an individual indicates either that they were consistently depressed or down, most of the day, nearly every day for the past two weeks or that they were less interested in doing most things or less able to enjoy the things that they used to enjoy most of the time, they are asked about 7 symptoms of depression. To meet criteria for a current major depressive episode, at least three symptoms must be endorsed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | HIV-related stigma was measured at baseline, post-treatment, and 3-month follow-up using the HIV/AIDS Stigma Instrument - People Living with AIDS (HASI-P). Three sub-scales from the full scale were used: negative self-perception (5 items), social isolation (5 items), and verbal abuse (8 items). Responses are rated on a four-point Likert scale from never (0) to most of the time (3). Subscale score ranges were 0-15 (negative self-perception and social isolation) and 0-24 (verbal abuse); subscale scores were summed to compute a total score (range 0-54). Higher scores indicate higher levels of stigma. |
| Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) | Social support was assessed using a modified version of the Duke-UNC Functional Social Support Questionnaire, a 10-item scale evaluating availability of emotional, informational, and tangible support. Items are rated on a 4-point Likert scale; number of persons providing support is also assessed. The maximum possible score is 40 and minimum score is 0; higher scores indicate greater perceived social support. |
Countries
South Africa, United States
Participant flow
Recruitment details
Participants were recruited between November 9, 2016 and March 3, 2017 from a district antenatal clinic in KwaZulu Natal, South Africa.
Participants by arm
| Arm | Count |
|---|---|
| Intervention: INSPireD This 5-8 session group intervention, Integrating Nuanced Support for Perinatal adherence and Depression, aimed to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and CBT for adherence and depression. | 14 |
| Control: Treatment-as-usual + Abbreviated Intervention The control group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study. | 9 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Reason Unknown | 4 | 7 |
Baseline characteristics
| Characteristic | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 24 years | 24 years |
| Current Employment Status Full-Time Employed | 2 Participants | 2 Participants | 4 Participants |
| Current Employment Status Not Employed | 10 Participants | 6 Participants | 16 Participants |
| Current Employment Status Part-Time Employed | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 9 Participants | 23 Participants |
| Highest Level of Schooling Complete Post-Secondary | 1 Participants | 0 Participants | 1 Participants |
| Highest Level of Schooling Incomplete Post-Secondary | 5 Participants | 4 Participants | 9 Participants |
| Highest Level of Schooling Up to Grade 12 | 8 Participants | 5 Participants | 13 Participants |
| In a Relationship with Father of Current Pregnancy No | 0 Participants | 1 Participants | 1 Participants |
| In a Relationship with Father of Current Pregnancy Yes | 14 Participants | 8 Participants | 22 Participants |
| Monthly Income 0-499 RAND | 3 Participants | 2 Participants | 5 Participants |
| Monthly Income 1000-1999 RAND | 1 Participants | 2 Participants | 3 Participants |
| Monthly Income 2000-2999 RAND | 0 Participants | 1 Participants | 1 Participants |
| Monthly Income 3000-3999 RAND | 0 Participants | 2 Participants | 2 Participants |
| Monthly Income 4000-4999 RAND | 2 Participants | 1 Participants | 3 Participants |
| Monthly Income 5000+ RAND | 4 Participants | 0 Participants | 4 Participants |
| Monthly Income 500-999 RAND | 0 Participants | 1 Participants | 1 Participants |
| Monthly Income Don't know | 4 Participants | 0 Participants | 4 Participants |
| Partner's HIV Status Don't know | 9 Participants | 5 Participants | 14 Participants |
| Partner's HIV Status HIV Negative | 0 Participants | 1 Participants | 1 Participants |
| Partner's HIV Status HIV Positive | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 14 participants | 9 participants | 23 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Trying to Get Pregnant No, not trying to get pregnant | 13 Participants | 7 Participants | 20 Participants |
| Trying to Get Pregnant Yes, trying to get pregnant | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 9 |
| other Total, other adverse events | 0 / 14 | 0 / 9 |
| serious Total, serious adverse events | 0 / 14 | 0 / 9 |
Outcome results
Adherence to Antiretroviral Therapy Per MEMS Caps
Objective ART adherence data were collected using the Medication Event Monitoring System (MEMS), which comprises a pill bottle with a digitized cap that measures and records when the bottle was opened each day. MEMS timepoints were defined as average MEMS use across the two-week period prior to each of the three assessment visits.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: Sixteen participants (12 intervention, 4 control) were included in the MEMS analysis at baseline, 12 (10 intervention, 2 control) were included at post-treatment, and 7 (6 intervention, 1 control) were included at 3-month follow-up. Data for 7 participants were not included at baseline due to: inconsistent use or non-use (n=2), lost to follow-up (n=4), and relocated (n=1).Three were excluded from final analyses due to broken caps or consistent cap non-use over the three measurement periods.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per MEMS Caps | Baseline | 99.4 percentage of MEMS-recorded adherence | Standard Deviation 2.2 |
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per MEMS Caps | Post-Treatment | 98.6 percentage of MEMS-recorded adherence | Standard Deviation 3 |
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per MEMS Caps | 3-Month Follow-Up | 92.8 percentage of MEMS-recorded adherence | Standard Deviation 6.4 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per MEMS Caps | Baseline | 92.9 percentage of MEMS-recorded adherence | Standard Deviation 14.3 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per MEMS Caps | Post-Treatment | 100.0 percentage of MEMS-recorded adherence | Standard Deviation 0 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per MEMS Caps | 3-Month Follow-Up | 85.7 percentage of MEMS-recorded adherence | — |
Adherence to Antiretroviral Therapy Per Self-Report
Adherence to ART during the previous month was measured through a composite score developed by Lu et al. (2008). The composite score combines the scores of three items into a single self-reported adherence score; the three items assess medication use frequency, percentage of time that the medication was taken as prescribed, and a rating of one's ability to take prescribed medication. The percent item had 11 response categories (0, 10, 20…100%), whereas the frequency and ability items had six response categories that were assigned scores of 0, 20, 40, 60, 80, and 100, with 100 considered to be perfect adherence.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per Self-Report | Baseline | 85.3 percentage of self-reported adherence | Standard Deviation 12.9 |
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per Self-Report | Post-Treatment | 92.8 percentage of self-reported adherence | Standard Deviation 8.7 |
| Intervention: INSPireD | Adherence to Antiretroviral Therapy Per Self-Report | 3-Month Follow-Up | 88.7 percentage of self-reported adherence | Standard Deviation 9.3 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per Self-Report | Baseline | 79.0 percentage of self-reported adherence | Standard Deviation 14 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per Self-Report | Post-Treatment | 77.8 percentage of self-reported adherence | Standard Deviation 15.4 |
| Control: Treatment-as-usual + Abbreviated Intervention | Adherence to Antiretroviral Therapy Per Self-Report | 3-Month Follow-Up | 89.2 percentage of self-reported adherence | Standard Deviation 5.9 |
Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
The 10-item Edinburgh Postnatal Depression Scale (EPDS) was used to measure depressive symptoms at baseline, post-treatment, and three-month follow-up; higher scores indicate more severe depressive symptoms. The minimum possible score is 0, and maximum score is 30. A standard clinical cutoff of 13 on the EPDS was used to distinguish women with and without probable depression.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: INSPireD | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | Baseline | 20.8 score on a scale | Standard Deviation 5.7 |
| Intervention: INSPireD | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | Post-Treatment | 1.2 score on a scale | Standard Deviation 1.7 |
| Intervention: INSPireD | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | 3-Month Follow-Up | 2.1 score on a scale | Standard Deviation 2.9 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | Baseline | 20.3 score on a scale | Standard Deviation 6.1 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | Post-Treatment | 11.8 score on a scale | Standard Deviation 9 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) | 3-Month Follow-Up | 6.5 score on a scale | Standard Deviation 9.2 |
Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
Current and past major depressive disorder was measured using the 17-item Major Depressive Episode Module of the Mini International Neuropsychiatric Interview (MINI). If an individual indicates either that they were consistently depressed or down, most of the day, nearly every day for the past two weeks or that they were less interested in doing most things or less able to enjoy the things that they used to enjoy most of the time, they are asked about 7 symptoms of depression. To meet criteria for a current major depressive episode, at least three symptoms must be endorsed.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: INSPireD | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | Baseline | 12 Participants |
| Intervention: INSPireD | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | Post-Treatment | 0 Participants |
| Intervention: INSPireD | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | 3-Month Follow-Up | 0 Participants |
| Control: Treatment-as-usual + Abbreviated Intervention | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | Baseline | 7 Participants |
| Control: Treatment-as-usual + Abbreviated Intervention | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | Post-Treatment | 2 Participants |
| Control: Treatment-as-usual + Abbreviated Intervention | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD | 3-Month Follow-Up | 1 Participants |
Level of Social Support Per Duke-UNC Functional Social Support Questionnaire
Social support was assessed using a modified version of the Duke-UNC Functional Social Support Questionnaire, a 10-item scale evaluating availability of emotional, informational, and tangible support. Items are rated on a 4-point Likert scale; number of persons providing support is also assessed. The maximum possible score is 40 and minimum score is 0; higher scores indicate greater perceived social support.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: INSPireD | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | Baseline | 33.9 score on a scale | Standard Deviation 5.8 |
| Intervention: INSPireD | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | Post-Treatment | 35.3 score on a scale | Standard Deviation 5.6 |
| Intervention: INSPireD | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | 3-Month Follow-Up | 36.4 score on a scale | Standard Deviation 5.5 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | Baseline | 27.7 score on a scale | Standard Deviation 9.6 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | Post-Treatment | 28.0 score on a scale | Standard Deviation 4.5 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire | 3-Month Follow-Up | 36.5 score on a scale | Standard Deviation 3.5 |
Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
HIV-related stigma was measured at baseline, post-treatment, and 3-month follow-up using the HIV/AIDS Stigma Instrument - People Living with AIDS (HASI-P). Three sub-scales from the full scale were used: negative self-perception (5 items), social isolation (5 items), and verbal abuse (8 items). Responses are rated on a four-point Likert scale from never (0) to most of the time (3). Subscale score ranges were 0-15 (negative self-perception and social isolation) and 0-24 (verbal abuse); subscale scores were summed to compute a total score (range 0-54). Higher scores indicate higher levels of stigma.
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Population: In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: INSPireD | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | Baseline | 14.3 score on a scale | Standard Deviation 10.2 |
| Intervention: INSPireD | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | Post-Treatment | 6.3 score on a scale | Standard Deviation 10.2 |
| Intervention: INSPireD | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | 3-Month Follow-Up | 2.5 score on a scale | Standard Deviation 6.7 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | Baseline | 24.3 score on a scale | Standard Deviation 12.6 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | Post-Treatment | 12.8 score on a scale | Standard Deviation 10.9 |
| Control: Treatment-as-usual + Abbreviated Intervention | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) | 3-Month Follow-Up | 12.5 score on a scale | Standard Deviation 17.7 |