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Randomized Controlled Trial
. 2022 May 1;90(1):69-78.
doi: 10.1097/QAI.0000000000002911.

Results of the Kigali Imbereheza Project: A 2-Arm Individually Randomized Trial of TI-CBT Enhanced to Address ART Adherence and Mental Health for Rwandan Youth Living With HIV

Geri R Donenberg  1   2 , Jessica Fitts  1 , Charles Ingabire  3 , Sabin Nsanzimana  4 , Mary Fabri  5 , Erin Emerson  1 , Eric Remera  4 , Olivier Manzi  6 , Bethany Bray  1 , Mardge H Cohen  5   7
Affiliations
Randomized Controlled Trial

Results of the Kigali Imbereheza Project: A 2-Arm Individually Randomized Trial of TI-CBT Enhanced to Address ART Adherence and Mental Health for Rwandan Youth Living With HIV

Geri R Donenberg et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Adolescents living with HIV have elevated mental distress and suboptimal antiretroviral therapy (ART) adherence.

Setting: Two urban clinics in Kigali, Rwanda.

Methods: A 2-arm individual randomized controlled trial compared Trauma-Informed Cognitive Behavioral Therapy enhanced to address HIV (TI-CBTe) with usual care (time-matched, long-standing, unstructured support groups) with 356 12- to 21-year-old (M = 16.78) Rwandans living with HIV. TI-CBTe included 6 group-based 2-hour sessions led by trained and supervised 21- to 25-year-old Rwandans living with HIV. Participants reported their ART adherence, depression/anxiety, and Post-Traumatic Stress Disorder symptoms at baseline, 6, 12, and 18 months.

Results: ART adherence was relatively high at baseline, and youth reported elevated rates of depression/anxiety and trauma symptoms. There were no differential treatment effects on adherence, but depression/anxiety improved over time. Youth with lower depression/anxiety at baseline seemed to benefit more from TI-CBTe than usual care, whereas women with high baseline distress seemed to benefit more from usual care. Youth were less likely to score in high Post-Traumatic Stress Disorder symptom categories at the follow-up, with no differential treatment effects.

Conclusions: TI-CBTe did not outperform usual care on ART adherence, possibly reflecting relatively high adherence at baseline, simplified medication regimens over time, a strong comparison condition, or because youth assigned to TI-CBTe returned to their support groups after the intervention. TI-CBTe was more effective for youth with lower depression/anxiety symptoms, whereas youth with high distress benefitted more from the support groups. TI-CBTe was feasible and acceptable, and young adults living with HIV were able to deliver a mental health intervention with fidelity. The powerful nature of the comparison group, ongoing support groups, points to the potential value of locally crafted interventions in low-resource settings.

Trial registration: ClinicalTrials.gov NCT02464423.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Consort Map.
See this image and copyright information in PMC

References

    1. UNAIDS. Global HIV & AIDS statistics - 2019 fact sheet. 2019. Accessed November 21, 2019.
    1. Ward H, Garnett GP, Mayer KH, et al. Maximizing the impact of HIV prevention technologies in sub-Saharan Africa. J Int AIDS Soc. 2019;22(Suppl 4):e25319. - PMC - PubMed
    1. UNAIDS. Communities at the Center: Defending rights, breaking barriers, reaching people with HIV services. 2019. Accessed November 21, 2019.
    1. UNAIDS. Miles to go - closing gaps, breaking barriers, righting injustices. Geneva: 2018.
    1. UNAIDS. Ending the AIDS epidemic for adolescents, with adolescents. Geneva: 2016.

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