HIV Infections
Conditions
Keywords
Syndemic Problems, ART Adherence, Food Insecurity, Depression, Post-traumatic Stress Disorder
Brief summary
In South Africa, the country with the highest HIV prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic problems) and are associated with worse HIV outcomes such as worse antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve ART adherence (CBT-SA); 3a) assess whether people are willing to receive the CBT-SA we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive CBT-SA.
Detailed description
South Africa (SA) has a generalized HIV epidemic, and the highest HIV prevalence rate (19%). Psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are associated with worse antiretroviral therapy (ART) adherence and higher viral load. Depression, post-traumatic stress, and food insecurity are also highly comorbid and are thought to interact synergistically to confer greater risk for worse HIV outcomes (i.e., syndemic problems). The proposed specific aims are to: 1) explore the complex interrelationships between food insecurity, depression, and post-traumatic stress, as they relate to engagement in HIV care, and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (CBT-SA) and conduct an iterative proof-of-concept pilot trial use syndemic theory; 3a) assess the feasibility and acceptability of CBT-SA in a pilot RCT; and 3b) identify barriers and facilitators of CBT-SA engagement among PWH and uptake among care providers and other key local partners to inform a future hybrid effectiveness/implementation R01 trial. If successful, this intervention would be further tested for effectiveness and implementation in a future application.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
We anticipate the intervention will contain the following: CBT for depression and trauma, Life-Steps for ART adherence, nutritional counseling, supplementary food parcels, case management, linkage to care. Specific intervention components will be informed by prior aims.
Sponsors
Massachusetts General Hospital
University of Cape Town
University of Miami
University of the Western Cape
University of Stellenbosch
University of Maryland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent assessors will be used to measure study outcomes of the RCT at follow-up assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient receiving HIV care in Khayelitsha (confirmed by medical record) 2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data) 3. Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following: * Clinically significant depressive symptoms (CES-D ≥ 16) * Clinically significant post-traumatic stress symptoms (SPAN ≥ 5) 4. 18 years of age or older
Exclusion criteria
1. Unable or unwilling to provide informed consent 2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling 3. Current untreated or undertreated serious mental health issue that would interfere with participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 75% of participants randomized to CBT-SA attend at least 66% of the sessions | 6-month follow-up | We will calculate the percentage of participants randomized to the CBT-SA condition who attend 66% or greater of the total number of sessions. CBT-SA will be considered feasible and acceptable if 75% of the participants attend 66% or more of the sessions. |
| 75% of the participants randomized to CBT-SA attend the 6-month follow-up visit. | 6-month follow-up | We will calculate the percentage of participants randomized to the CBT-SA condition who attend the 6-month follow-up visit. CBT-SA will be considered feasible and acceptable if 75% of the participants attend the 6-month follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ART adherence | 6-month follow-up | ART adherence via dried blood spots on TDF-based regimens |
| Presence of depression measured by the DIAMOND diagnostic instrument | 6-month follow-up | Whether participants meet criteria or not on the depression module of the DIAMOND Diagnostic Measure. |
| Presence of PTSD measured by the DIAMOND diagnostic instrument | 6-month follow-up | Whether participants meet criteria or not on the PTSD module of the DIAMOND Diagnostic Measure. |
Countries
South Africa
Contacts
CONTACTJasper S Lee, Ph.D.
PRINCIPAL_INVESTIGATORConall O'Cleirigh, PhD
Massachusetts General Hospital
Outcome results
None listed