Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social, Disclosure, Quality of Life
Conditions
Brief summary
The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement. The investigators hypothesize that a brief telehealth counseling intervention will be safe (participants in the clinical trial will not have increased risk of suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate preliminary efficacy (reduced suicidal ideation, improved care engagement, improved mental well-being).
Detailed description
The objective of the proposed research is to assess the feasibility and acceptability of a 3-session, nurse-delivered telehealth intervention to reduce suicidality and improve HIV care engagement among adults living with HIV in the Kilimanjaro Region of Tanzania. Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and mental health disorders are key contributors to poor HIV care engagement, lower quality of life, higher transmission risk, and increased mortality among PLWH. Conversely, connecting PLWH with targeted mental health support improves these critical health outcomes. Telehealth counseling represents a cost-effective, innovative approach to mental health treatment in low-resource settings such as Tanzania, with the potential to expediently extend services. The proposed study will include Aim 1: Identifying the desired characteristics of a telehealth intervention for suicidality and HIV care engagement in the Tanzanian clinical context, Aim 2: Refining intervention content with support from a local study advisory board in Tanzania, and Aim 3: Testing the telehealth model in a pilot randomized control trial. Given emerging evidence for telehealth approaches to improve access to treatment and reduce health disparities, the intervention has great potential to support NIMH strategic objectives to address mental health comorbidities and strengthen the HIV care continuum.
Interventions
BEHAVIORALIDEAS for Hope
Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.
BEHAVIORALEnhanced Standard of Care (Safety Planning)
Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
Sponsors
National Institute of Mental Health (NIMH)
Kilimanjaro Christian Medical Centre, Tanzania
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients who screen positive for suicidal ideation will be enrolled in the study, complete the baseline survey, and then randomly assigned to the intervention (3 sessions of counseling) or enhanced standard of care (brief safety planning).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Attending HIV care at study clinic * Screen positive for suicidal ideation * Able to understand Kiswahili or English * Medically stable * Capable of providing informed consent to participate
Exclusion criteria
* Under 18 years old * Unable to understand Kiswahili or English * Experiencing medical or psychiatric symptoms requiring immediate treatment * Incapable of providing informed consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suicidal Ideation | 3 months post enrollment | Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items. |
| Number of Participants With a Gap in HIV Care Engagement | 3 months post enrollment | Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments. |
| HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges | 3 months post enrollment | During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: Think about the last 14 days. On how many days did you miss taking your HIV pill(s)? and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days. |
| Viral Load | Baseline, 3 months Post Enrollment | Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support | 3 months post enrollment | Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support |
| Acceptability of Intervention | 3 months post enrollment | 10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention |
| Hopelessness | 3 months post enrollment | Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness |
| Depression | 3 months post enrollment | Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression |
| Quality of Life (Overall) | 3 months post enrollment | The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life |
| Quality of Life (Health Satisfaction) | 3 months post enrollment | The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life |
| Reasons for Living | 3 months post enrollment | Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live |
| HIV Stigma | 3 months post enrollment | HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma |
| Number of HIV Disclosures Made by Participants | 3 months post enrollment | Self-reported disclosures to partner, family, friends, others (yes/no) |
| Total Number of HIV Disclosures Made by Participants | 3 months post enrollment | — |
Countries
Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDEAS for Hope Intervention Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.
IDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement. | 30 |
| Enhanced Standard of Care With Safety Planning Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
Enhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | IDEAS for Hope Intervention | Total | Enhanced Standard of Care With Safety Planning |
|---|---|---|---|
| Age, Continuous | 43.83 years STANDARD_DEVIATION 11.86 | 43.25 years STANDARD_DEVIATION 11.36 | 42.67 years STANDARD_DEVIATION 10.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 | 30 Participants | 60 Participants | 30 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 Tanzania | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 23 Participants | 47 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
Outcome results
Primary
HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges
During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: Think about the last 14 days. On how many days did you miss taking your HIV pill(s)? and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IDEAS for Hope Intervention | HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges | 1 Participants |
| Enhanced Standard of Care With Safety Planning | HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges | 2 Participants |
Comparison: Generalized linear mixed models were conducted and odds ratios (ORs) were reportedp-value: 0.368Mixed Models Analysis
Primary
Number of Participants With a Gap in HIV Care Engagement
Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IDEAS for Hope Intervention | Number of Participants With a Gap in HIV Care Engagement | 2 Participants |
| Enhanced Standard of Care With Safety Planning | Number of Participants With a Gap in HIV Care Engagement | 1 Participants |
Comparison: Generalized linear mixed models were conducted and odds ratios (ORs) were reportedp-value: 0.961Mixed Models Analysis
Primary
Number of Participants With Suicidal Ideation
Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items.
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDEAS for Hope Intervention | Number of Participants With Suicidal Ideation | Suicidal Thoughts | 4 Participants |
| IDEAS for Hope Intervention | Number of Participants With Suicidal Ideation | Plan | 0 Participants |
| IDEAS for Hope Intervention | Number of Participants With Suicidal Ideation | Intent | 0 Participants |
| Enhanced Standard of Care With Safety Planning | Number of Participants With Suicidal Ideation | Suicidal Thoughts | 3 Participants |
| Enhanced Standard of Care With Safety Planning | Number of Participants With Suicidal Ideation | Plan | 0 Participants |
| Enhanced Standard of Care With Safety Planning | Number of Participants With Suicidal Ideation | Intent | 0 Participants |
Comparison: Generalized linear mixed models were conducted and odds ratios (ORs) were reportedp-value: 0.961Mixed Models Analysis
Primary
Viral Load
Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.
Time frame: Baseline, 3 months Post Enrollment
Population: Data not collected.
Secondary
Acceptability of Intervention
10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Acceptability of Intervention | 34.93 score on a scale | Standard Deviation 3.11 |
| Enhanced Standard of Care With Safety Planning | Acceptability of Intervention | 33.5 score on a scale | Standard Deviation 2.78 |
Comparison: General linear mixed modelsp-value: 0.7Mixed Models Analysis
Secondary
Depression
Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Depression | 2.71 score on a scale | Standard Deviation 2.43 |
| Enhanced Standard of Care With Safety Planning | Depression | 3.13 score on a scale | Standard Deviation 2.87 |
Comparison: General linear mixed modelsp-value: 0.634Mixed Models Analysis
Secondary
HIV Stigma
HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | HIV Stigma | 29.35 score on a scale | Standard Deviation 3.49 |
| Enhanced Standard of Care With Safety Planning | HIV Stigma | 30.31 score on a scale | Standard Deviation 5.39 |
Comparison: General linear mixed modelsp-value: 0.832Mixed Models Analysis
Secondary
Hopelessness
Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Hopelessness | 1.75 score on a scale | Standard Deviation 2.12 |
| Enhanced Standard of Care With Safety Planning | Hopelessness | 2.4 score on a scale | Standard Deviation 2.33 |
Comparison: General linear mixed modelsp-value: 0.79Mixed Models Analysis
Secondary
Number of HIV Disclosures Made by Participants
Self-reported disclosures to partner, family, friends, others (yes/no)
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDEAS for Hope Intervention | Number of HIV Disclosures Made by Participants | Disclosed to partner | 2 Disclosures |
| IDEAS for Hope Intervention | Number of HIV Disclosures Made by Participants | Disclosed to family | 0 Disclosures |
| IDEAS for Hope Intervention | Number of HIV Disclosures Made by Participants | Disclosed to friends | 4 Disclosures |
| IDEAS for Hope Intervention | Number of HIV Disclosures Made by Participants | Disclosed to others | 0 Disclosures |
| Enhanced Standard of Care With Safety Planning | Number of HIV Disclosures Made by Participants | Disclosed to others | 2 Disclosures |
| Enhanced Standard of Care With Safety Planning | Number of HIV Disclosures Made by Participants | Disclosed to partner | 1 Disclosures |
| Enhanced Standard of Care With Safety Planning | Number of HIV Disclosures Made by Participants | Disclosed to friends | 2 Disclosures |
| Enhanced Standard of Care With Safety Planning | Number of HIV Disclosures Made by Participants | Disclosed to family | 2 Disclosures |
Secondary
Quality of Life (Health Satisfaction)
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Quality of Life (Health Satisfaction) | 3.79 score on a scale | Standard Deviation 0.74 |
| Enhanced Standard of Care With Safety Planning | Quality of Life (Health Satisfaction) | 3.73 score on a scale | Standard Deviation 0.91 |
p-value: 0.942Mixed Models Analysis
Secondary
Quality of Life (Overall)
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Quality of Life (Overall) | 3.54 score on a scale | Standard Deviation 0.84 |
| Enhanced Standard of Care With Safety Planning | Quality of Life (Overall) | 3.60 score on a scale | Standard Deviation 0.62 |
p-value: 0.823Mixed Models Analysis
Secondary
Reasons for Living
Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Reasons for Living | 60.54 score on a scale | Standard Deviation 8.79 |
| Enhanced Standard of Care With Safety Planning | Reasons for Living | 62.3 score on a scale | Standard Deviation 5.49 |
Comparison: General linear mixed modelsp-value: 0.55Mixed Models Analysis
Secondary
Social Support
Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Social Support | 27.21 score on a scale | Standard Deviation 7.15 |
| Enhanced Standard of Care With Safety Planning | Social Support | 27.9 score on a scale | Standard Deviation 7.42 |
Comparison: General linear mixed modelsp-value: 0.833Mixed Models Analysis
Secondary
Total Number of HIV Disclosures Made by Participants
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDEAS for Hope Intervention | Total Number of HIV Disclosures Made by Participants | 6 Disclosures |
| Enhanced Standard of Care With Safety Planning | Total Number of HIV Disclosures Made by Participants | 7 Disclosures |
Comparison: Generalized linear mixed models were conducted and odds ratios (ORs) were reportedp-value: 0.624Mixed Models Analysis
Post Hoc
Anxiety
Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Anxiety | 5.5 score on a scale | Standard Deviation 4.22 |
| Enhanced Standard of Care With Safety Planning | Anxiety | 7.43 score on a scale | Standard Deviation 5.71 |
Comparison: General linear mixed modelsp-value: 0.207Mixed Models Analysis
Post Hoc
Attitudes About Antiretroviral Therapy
Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Attitudes About Antiretroviral Therapy | 42.25 score on a scale | Standard Deviation 3.53 |
| Enhanced Standard of Care With Safety Planning | Attitudes About Antiretroviral Therapy | 42.73 score on a scale | Standard Deviation 4.59 |
Comparison: General linear mixed modelsp-value: 0.738Mixed Models Analysis
Post Hoc
HIV Acceptance
Illness Cognition Questionnaire (ICQ), 7 items, score 7-28 with higher indicating more acceptance
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | HIV Acceptance | 20.75 score on a scale | Standard Deviation 2.77 |
| Enhanced Standard of Care With Safety Planning | HIV Acceptance | 20.73 score on a scale | Standard Deviation 3.86 |
Comparison: General linear mixed modelsp-value: 0.845Mixed Models Analysis
Post Hoc
Suicide Coping Self-Efficacy
Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy
Time frame: 3 months post enrollment
Population: 1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEAS for Hope Intervention | Suicide Coping Self-Efficacy | 45.86 score on a scale | Standard Deviation 11.51 |
| Enhanced Standard of Care With Safety Planning | Suicide Coping Self-Efficacy | 43.53 score on a scale | Standard Deviation 11.99 |
Comparison: General linear mixed modelsp-value: 0.594Mixed Models Analysis