Protocol for a pilot randomized controlled trial of a telehealth-delivered counseling intervention to reduce suicidality and improve HIV care engagement in Tanzania

Abstract

Objective: Suicidal ideation is strikingly common among people living with HIV (PLWH) worldwide, leading to higher burden of disease, poor HIV care engagement, and loss of life. In low- and middle-income countries such as Tanzania, mental health resources are scarce, requiring innovative strategies for treatment. We describe the protocol for a clinical trial of a three-session telehealth counseling intervention to reduce suicidality and improve HIV care engagement in Tanzania.

Methods: In a pilot randomized controlled trial, we will assess the feasibility, acceptability, and potential efficacy of a new telehealth intervention, termed "IDEAS for Hope". A total of 60 PLWH will be enrolled from two HIV clinics in the Kilimanjaro region and connected to telehealth counsellors based at a large regional hospital. Participants will be ≥18 years old and speak either Kiswahili or English. Patient screening will occur during routine HIV clinical care to identify PLWH experiencing suicidal ideation. Baseline surveys will be administered upon enrollment and participants will be randomized 1:1 to receive either IDEAS for Hope or the comparison condition, a brief safety planning session. All participants will receive an additional referral for psychiatric treatment. Follow-up assessment will occur at three months. IDEAS for Hope is informed by a Motivational Interviewing-enhanced safety planning intervention (MI-SafeCope) and our formative work in Tanzania. The model consists of Four Pillars: living healthy with HIV, managing HIV stigma, seeking social support, and meeting basic needs. Together, these mechanisms serve as a foundation for developing a sense of safety and hope for the future. Outcome measures will include intervention feasibility, acceptability, participant suicidality, and HIV care engagement.

Significance: Innovative, telehealth-based counseling represents a promising treatment for suicidality among PLWH in low-resource settings. Results from this pilot trial will inform intervention refinement and parameter estimates for a future clinical trial powered to evaluate effectiveness.

Fig 1. SPIRIT schedule of enrolment, interventions, assessments.

ART: antiviral therapy, BHS: Beck Hopelessness Scale, BRFL: Brief Reasons for Living Inventory, BSI: brief symptom inventory, BMQ: Beliefs about Medicines Questionnaire, C-SSRS: Columbia-Suicide Severity Rating Scale, HSS: HIV Stigma Scale, HXMI: History of Mental Health Illness & Treatment, ICQ: Illness Cognition Questionnaire, PASS: Perceived Availability of Social Support, PHQ: Patient Health Questionnaire: SEASA: Self-Efficacy to Avoid Suicidal Action.

Fig 2. Flow diagram.

Fig 3. The four pillars framework.

(Knettel, 2023, used with permission).