Recruitment and Baseline Characteristics of Participants in the Social, Emotional, and Economic Empowerment Through Knowledge of Group Support Psychotherapy Study (SEEK-GSP): Cluster Randomized Controlled Trial

Etheldreda Nakimuli-Mpungu; Seggane Musisi; Kizito Wamala; James Okello; Sheila Ndyanabangi; Josephine Birungi; Mastula Nanfuka; Michael Etukoit; Ramin Mojtabai; Jean Nachega; Ofir Harari; Edward Mills

doi:10.2196/11560

Recruitment and Baseline Characteristics of Participants in the Social, Emotional, and Economic Empowerment Through Knowledge of Group Support Psychotherapy Study (SEEK-GSP): Cluster Randomized Controlled Trial

JMIR Res Protoc. 2019 Jan 3;8(1):e11560. doi: 10.2196/11560.

Authors

Etheldreda Nakimuli-Mpungu^#¹, Seggane Musisi¹, Kizito Wamala², James Okello³, Sheila Ndyanabangi⁴, Josephine Birungi⁵, Mastula Nanfuka⁵, Michael Etukoit⁵, Ramin Mojtabai⁶, Jean Nachega^{7

8

9

10}, Ofir Harari¹¹, Edward Mills¹²

Affiliations

¹ Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.
² Center for Victims of Torture, Department of Psychology, Gulu, Uganda.
³ Department of Mental Health, Faculty of Medicine, Gulu University, Gulu, Uganda.
⁴ Mental Health Program, Ministry of Health of Uganda, Kampala, Uganda.
⁵ The AIDS Support Organization (TASO), Kampala, Uganda.
⁶ Department of Mental Health, Bloomberg's School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
⁷ Department of Epidemiology, Pittsburg Graduate School of Public Health, University of Pittsburg, Pittsburgh, PA, United States.
⁸ Stellenbosch Center for Infectious Disease, Department of Medicine, Stellenbosch University, Cape Town, South Africa.
⁹ Department of Epidemiology, Bloomberg's School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
¹⁰ Department of International Health, Bloomberg's School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
¹¹ MTEK Sciences Inc, Vancouver, BC, Canada.
¹² Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada.

^# Contributed equally.

PMID: 30609989
PMCID: PMC6682267
DOI: 10.2196/11560

Abstract

Background: Psychosocial characteristics, including self-esteem, perceived social support, coping skills, stigma, discrimination, and poverty, are strongly correlated with depression symptoms. However, data on the extent of these correlations among persons living with HIV and the associations between psychosocial characteristics and HIV treatment outcomes are limited in sub-Saharan Africa.

Objective: This paper aims to describe the recruitment process and baseline characteristics associated with depression in a sample of HIV-positive people in a cluster randomized trial of group support psychotherapy (GSP) for depression delivered by trained lay health workers (LHWs).

Methods: Thirty eligible primary care health centers across three districts in Uganda were randomly allocated to have their LHWs trained to deliver GSP (intervention arm) or group HIV education and treatment as usual (control arm) to persons living with HIV comorbid with depression. Baseline demographic, socioeconomic, and psychosocial characteristics were collected via interviewer-administered questionnaires. Among eligible participants, differences between those enrolled versus those who refused enrollment were assessed using chi square for categorical variables and t tests for continuous variables. Spearman rank order correlation analyses were conducted to determine associations between baseline depression symptoms and adherence to antiretroviral therapy (ART), viral load suppression, and other psychosocial variables.

Results: The study screened 1473 people and 1140 were found to be eligible and enrolled over 14 weeks. Participants recruited comprised 95% of the target sample size of 1200. The sample's mean age was 38.5 (SD 10.9) years and both genders were well represented (males: 46.32%, 528/1140). Most participants met the diagnostic criteria for major depressive disorder (96.92%, 1105/1140), had significant posttraumatic stress symptoms (72.46%, 826/1140), reported moderate suicide risk (52.54%, 599/1140), had primary or no formal education (86.22%, 983/1140), and reported no income-generating activity (72.63%, 828/1140) and no food insecurity (81.67%, 931/1140). Among eligible participants, 48 of 1140 (4.21%) refused to participate in the interventions; these participants were more likely to be males (χ²₁=4.0, P=.045) and have significantly lower depression symptoms scores (t₂=2.36, P=.01) than those who participated in the interventions. There was a significant positive correlation between viral load and number of traumatic experiences (ρ=.12, P=.05). Adherence to ART was positively correlated with perceived social support (ρ=.15, P<.001), but negatively correlated with depression symptoms (ρ=-.11, P=.05) and stigma (ρ=-.14, P<.001).

Conclusions: Men and women with HIV and depression experience multiple social and economic vulnerabilities and disadvantages. Culturally tailored psychological interventions aimed at these individuals should address these socioeconomic disadvantages in addition to addressing their mental health care needs.

Trial registration: Pan African Clinical Trials Registry PACTR201608001738234; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1738 (Archived by WebCite at http://www.webcitation.org/74NtMphom).

Keywords: Uganda; cluster randomized trial; depression; group support psychotherapy; lay health workers; persons living with HIV/AIDS; psychosocial stressors; recruitment.

©Etheldreda Nakimuli-Mpungu, Seggane Musisi, Kizito Wamala, James Okello, Sheila Ndyanabangi, Josephine Birungi, Mastula Nanfuka, Michael Etukoit, Ramin Mojtabai, Jean Nachega, Ofir Harari, Edward Mills. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.01.2019.