(C) PLOS One [1]. This unaltered content originally appeared in journals.plosone.org. Licensed under Creative Commons Attribution (CC BY) license. url:https://journals.plos.org/plosone/s/licenses-and-copyright ------------ Peer-led counselling with problem discussion therapy for adolescents living with HIV in Zimbabwe: A cluster-randomised trial ['Victoria Simms', 'Mrc International Statistics', 'Epidemiology Group', 'London School Of Hygiene', 'Tropical Medicine', 'London', 'United Kingdom', 'Helen A. Weiss', 'Silindweyinkosi Chinoda', 'Friendship Bench'] Date: 2022-01 Abstract Background Adolescents living with HIV have poor virological suppression and high prevalence of common mental disorders (CMDs). In Zimbabwe, the Zvandiri adolescent peer support programme is effective at improving virological suppression. We assessed the effect of training Zvandiri peer counsellors known as Community Adolescent Treatment Supporters (CATS) in problem-solving therapy (PST) on virological suppression and mental health outcomes. Methods and findings Sixty clinics were randomised 1:1 to either normal Zvandiri peer counselling or a peer counsellor trained in PST. In January to March 2019, 842 adolescents aged 10 to 19 years and living with HIV who screened positive for CMDs were enrolled (375 (44.5%) male and 418 (49.6%) orphaned of at least one parent). The primary outcome was virological nonsuppression (viral load ≥1,000 copies/mL). Secondary outcomes were symptoms of CMDs measured with the Shona Symptom Questionnaire (SSQ ≥8) and depression measured with the Patient Health Questionnaire (PHQ-9 ≥10) and health utility score using the EQ-5D. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression adjusting for clinic-level clustering. Case reviews and focus group discussions were used to determine feasibility of intervention delivery. At baseline, 35.1% of participants had virological nonsuppression and 70.3% had SSQ≥8. After 48 weeks, follow-up was 89.5% for viral load data and 90.9% for other outcomes. Virological nonsuppression decreased in both arms, but there was no evidence of an intervention effect (prevalence of nonsuppression 14.7% in the Zvandiri-PST arm versus 11.9% in the Zvandiri arm; AOR = 1.29; 95% CI 0.68, 2.48; p = 0.44). There was strong evidence of an apparent effect on common mental health outcomes (SSQ ≥8: 2.4% versus 10.3% [AOR = 0.19; 95% CI 0.08, 0.46; p < 0.001]; PHQ-9 ≥10: 2.9% versus 8.8% [AOR = 0.32; 95% CI 0.14, 0.78; p = 0.01]). Prevalence of EQ-5D index score <1 was 27.6% versus 38.9% (AOR = 0.56; 95% CI 0.31, 1.03; p = 0.06). Qualitative analyses found that CATS-observed participants had limited autonomy or ability to solve problems. In response, the CATS adapted the intervention to focus on empathic problem discussion to fit adolescents’ age, capacity, and circumstances, which was beneficial. Limitations include that cost data were not available and that the mental health tools were validated in adult populations, not adolescents. Conclusions PST training for CATS did not add to the benefit of peer support in reducing virological nonsuppression but led to improved symptoms of CMD and depression compared to standard Zvandiri care among adolescents living with HIV in Zimbabwe. Active involvement of caregivers and strengthened referral structures could increase feasibility and effectiveness. Trial registration Pan African Clinical Trials Registry PACTR201810756862405. Author summary Why was this study done? Common mental disorders (CMDs) such as anxiety and depression are highly prevalent among adolescents living with HIV. It is important to identify strategies to treat CMDs in this population. The Friendship Bench is a proven effective mental health intervention based on problem-solving therapy (PST), which is delivered by trained lay counsellors. The Zvandiri programme is a proven effective intervention to improve HIV outcomes among adolescents, delivered by trained peer counsellors. It is not known whether PST could improve mental health, and HIV outcomes, among adolescents living with HIV, when delivered in addition to the Zvandiri programme. What did the researchers do and find? We conducted a trial among 842 adolescents living with HIV in Zimbabwe, who also had CMDs (depression and anxiety), and attended public health clinics for HIV care. We randomly allocated 30 clinics to provide Zvandiri peer counselling to adolescents living with HIV, and a further 30 clinics to provide Zvandiri counselling plus the Friendship Bench PST. After a year, there was no difference in the proportion with unsuppressed HIV viral load, and this was low in both groups. There was a substantial improvement in mental health (depression and anxiety) in both groups, with significantly better outcomes among those in the Friendship Bench group. The peer counsellors adapted their training and focused on problem discussion rather than problem-solving, because many adolescents identified problems that they did not have the resources to solve. What do these findings mean? To our knowledge, this is the first study to show that an intervention can improve mental health among adolescents living with HIV who have mental health disorders. The lack of an impact on HIV viral load, compared to the Zvandiri programme, might be because of the effectiveness of the Zvandiri counselling and the presence of resistance to HIV drugs in a small number of participants. Mental healthcare should be integrated in HIV care for adolescents. It should be age specific, with shorter sessions than for adults, creating a space for discussing and sharing problems, and involving caregivers as appropriate. Citation: Simms V, Weiss HA, Chinoda S, Mutsinze A, Bernays S, Verhey R, et al. (2022) Peer-led counselling with problem discussion therapy for adolescents living with HIV in Zimbabwe: A cluster-randomised trial. PLoS Med 19(1): e1003887. https://doi.org/10.1371/journal.pmed.1003887 Academic Editor: Jacob Bor, Boston University School of Public Health, UNITED STATES Received: June 20, 2021; Accepted: December 9, 2021; Published: January 5, 2022 Copyright: © 2022 Simms et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: All data files are available from the LSHTM Data Compass repository https://datacompass.lshtm.ac.uk/id/eprint/2142/. Funding: DC and NW were awarded grant G-1710-02137 by the Children's Investment Fund Foundation (https://ciff.org/). VS and HAW are partly funded by the UK Medical Research Council (MRC) and the UK Foreign, Commonwealth and Development Office (FCDO) under the MRC/FCDO Concordat agreement and is also part of the EDCTP2 programme supported by the European Union. Grant Ref: MR/R010161/1 The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Abbreviations: AMD, adjusted mean difference; AOR, adjusted odds ratio; ART, antiretroviral therapy; CATS, Community Adolescent Treatment Supporters; CI, confidence interval; CMD, common mental disorder; CRT, cluster-randomised controlled trial; DBS, dried blood spot; FGD, focus group discussion; MoHCC, Ministry of Health and Child Care; PHQ, Patient Health Questionnaire; PST, problem-solving therapy; SMART, specific, measurable, achievable, realistic, and timely; SSQ, Shona Symptom Questionnaire; WHO, World Health Organisation Introduction Common mental disorders (CMDs) such as anxiety and depression are highly prevalent among adolescents living with HIV [1]. CMDs affect quality of life directly and are associated with impaired adherence to antiretroviral therapy (ART) and, therefore, with the increased resistance, morbidity, and mortality. Adolescents living with HIV have poorer virological suppression than any other age group [2]. The World Health Organisation (WHO) updated recommendations on service delivery for the treatment and care of people living with HIV [3] make a strong recommendation that psychosocial interventions should be provided to all adolescents and young adults living with HIV. One of the programmes underpinning this recommendation is Zvandiri, a WHO best practice programme [4] for adolescents living with HIV in Zimbabwe. The core of the Zvandiri approach is Community Adolescent Treatment Supporters (CATS). CATS are young people aged 18 to 24 years living with HIV who are trained and mentored to provide peer counselling and support. A cluster-randomised controlled trial (CRT) showed that the Zvandiri programme was more effective than standard of care at improving HIV virological suppression of adolescents but was not more effective for treating CMDs [5]. In qualitative interviews, participants reported that they found aspects of the intervention beneficial for mental health. Friendship Bench is a counselling programme delivered by trained lay health workers, with a focus on problem-solving therapy (PST). PST is a cognitive-behavioural approach, which develops cognitive tools for problem solving, and builds adaptive skills and an enhanced sense of agency [6]. Friendship Bench was developed for adults and has been adapted for youth. In adults, it has been proven effective at improving mental health outcomes compared to standard of care [6]. The Friendship Bench program focuses on exploration and understanding of the clients’ situational context through talk therapy, mentalization, positive relational experience through being listened to, and intrapersonal growth towards strength and ability through goal-oriented learning. The aim of the current trial was to evaluate whether enhancing the counselling skills of CATS to provide PST reduces virological nonsuppression and improves mental health among adolescents living with HIV in Zimbabwe, compared with standard Zvandiri care. Methods The study design and methods have been fully described in a protocol paper [7]. Briefly, the Zvandiri programme was operational in 60 clinics (clusters), 6 in each of 10 districts across Zimbabwe. The clinics had previously been selected for a scale-up of the Zvandiri programme. In each district, the 6 clinics were randomly allocated 1:1 to the Zvandiri-PST arm or the Zvandiri arm by an independent statistician using a prewritten randomisation code. There was no allocation concealment. All participants attending clinics allocated to the Zvandiri arm received Zvandiri standard care, consisting of HIV care following Ministry of Health and Child Care (MoHCC) guidelines [8], plus counselling and home visits from trained, mentored CATS, monthly support groups, and weekly text messages and home visits. Participants at the Zvandiri-PST clinics received the same, plus additional sessions based on the CATS’ PST training. The CATS in the Zvandiri-PST arm met a Zvandiri mentor at least once every 2 weeks to review individual cases. The PST consisted of a series of steps described in the Friendship Bench manual [9]. The first step is “kuvhura pfungwa” (opening up the mind), in which the client makes a list of all their problems. In the next step, “kusimudzira” (uplifting), the counsellor helps the client choose one manageable, relevant problem, establish a goal, and brainstorm solutions. The third step, “kusimbisa” (strengthening), focuses on selecting a detailed solution and devising a specific, measurable, achievable, realistic, and timely (SMART) action plan to carry it out. Finally, in the fourth step, “kusimbisisa” (further strengthening), clients are invited to join a support group. Adolescents living with HIV aged 10 to 19 years who were taking ART were screened using the 14-item Shona Symptom Questionnaire (SSQ), a locally developed and validated instrument to assess symptoms of CMD [10,11]. Those scoring ≥7/14 who did not meet any of the exclusion criteria (unable to comprehend the nature of the study in either English, Shona, or Ndebele, currently in psychiatric care, end stage AIDS, current psychosis, intoxication, and/or cognitive disability) were enrolled after obtaining written consent from the caregiver and assent from the adolescent (or consent from the adolescent if aged 18 to 19). Those who were too unwell to participate or unable to give informed consent were excluded. The trial was registered with the Pan African Clinical Trials Registry (PACTR201810756862405) and approved by the ethics committees of the Medical Research Council of Zimbabwe and the London School of Hygiene & Tropical Medicine. Quantitative data collection and analysis The primary outcome was the proportion of participants with virological failure (defined as ≥1,000 copies/ml) or death at 48 weeks after enrolment (plus or minus 8 weeks). Viral load was obtained from a dried blood spot (DBS) sample. Secondary outcomes were the proportion of participants with symptoms of CMD, defined as a score of ≥8/14 on the SSQ [11], and proportion with symptoms of depression, defined as a score of ≥10/27 on the Patient Health Questionnaire (PHQ-9) [11]. Poor quality of life was assessed as a secondary outcome using the EQ-5D scale converted to an index using validated Zimbabwe utility scores [12,13] and analysed as a binary variable (1 versus <1), as the highly skewed distribution of scores did not allow for analysis as a continuous outcome. Severity of mental health symptoms was assessed using the SSQ and PHQ-9 as continuous scores. The sample size of 840 participants recruited from 60 clusters provided 85% power to detect a difference in virological nonsuppression of 43% among participants in the Zvandiri arm versus 30% in the Zvandiri-PST arm assuming 20% loss to follow-up and a coefficient of variation (k) between clusters of 0.25. For secondary outcomes, the sample size provided 87% power to detect a difference in the proportion with CMD symptoms at 12 months of 16% in the Zvandiri arm and 8% in the Zvandiri-PST arm. The predicted outcomes in the Zvandiri arm were based on baseline results of a previous trial [5]. At baseline, data collection was predominantly paper based. A private company (Datalyst) completed double entry and validation of data. At endline, data were collected using a preprogrammed form in ODK on Android tablets. Data were exported to Stata 15.1 for cleaning and analysis, following a prespecified analytical plan. Statisticians were blinded to study arm until analysis was complete. Data were collected by CATS, so it was not possible to blind them to study arm. Analysis used intention-to-treat principles, retaining participants in the arm to which they were randomised. In a prewritten analytical plan (S1 Text), an a priori decision was made to adjust for baseline values of the relevant outcome measure and for key variables that were deemed imbalanced between arms at baseline or were associated with missing outcome data. The primary analysis was complete case. For binary outcomes, logistic regression random effects models were used to estimate adjusted odds ratios (AORs) and 95% confidence interval (CI), with a random effects term to allow for clustering by clinic. A quadrature check was performed to evaluate the model fit. For continuous outcomes, analogous mixed effects linear regression models were used to estimate adjusted mean differences (AMDs) and 95% CI. Prespecified effect modification by age group at baseline of the intervention effect on the primary and secondary outcomes was assessed by fitting separate models for the 10 to 14 and 15 to 19 age groups. Qualitative data collection and analysis To better understand how the CATS experienced implementing the intervention, including its feasibility and any necessary modifications, we collected qualitative data to capture concurrent and retrospective accounts of the CATS (Table 1). Case reviews between 20 individual CATS and their mentors were conducted each month over the 12-month trial duration. Two focus group discussions (FGDs) were held with 20 CATS at the end of the trial. Conducted by Zvandiri researchers at the Africaid offices in Harare, the FGDs involved a range of activities to facilitate reflective discussion. All data collection was conducted in the local languages and audio recorded. Data were transcribed and translated into English. A thematic analytical approach was adopted [14]. Analytical memos and weekly analytical team meetings were also used in the development of themes and identification of patterns related to CATS experiences across the datasets [15]. See S1 CONSORT Checklist. PPT PowerPoint slide PNG larger image TIFF original image Download: Table 1. Description of qualitative data collection. https://doi.org/10.1371/journal.pmed.1003887.t001 Discussion Among adolescents with HIV and comorbid symptoms of CMD, peer mental health counselling showed no evidence of an impact on the primary outcome of virological nonsuppression but did show apparent evidence of improved mental health. To our knowledge, this is the first trial to show evidence of improved mental health in this population group. Those who received care from a PST-trained CATS had substantially lower prevalence of CMD and depression symptoms after 1 year, compared to those receiving care from a CATS without PST training. There was weak evidence of improved quality of life (EQ-5D). Mental health outcomes improved over time in both trial arms. This trial adds to the sparse literature on mental health interventions for adolescents living with HIV in low- and middle-income settings (LMIC). A recent systematic review identified only 3 such studies [16]. Two were pilot studies that were not powered to assess effectiveness [17,18], and the third was an analysis of the baseline characteristics of trial participants [19]. The results of the current trial extend those of our previous trial, which was conducted among adolescents living with HIV and was not restricted to those with symptoms of CMD. In that trial, which compared the Zvandiri programme delivered by CATS (i.e., the control arm in the current trial) with standard HIV care, 20.4% of participants had an SSQ score ≥8 at enrolment. We found an intervention effect on virological nonsuppression or death but not on mental health outcomes [5]. Prevalence of virological nonsuppression or death was 24.9% in the Zvandiri arm versus 35.9% in the standard HIV care arm after 2 years (adjusted prevalence ratio = 0.58; 95% CI 0.36 to 0.94). In our present trial, there was a substantial reduction in virological nonsuppression in both arms (33.7% to 11.9% in the Zvandiri arm, 36.4% to 14.7 in the Zvandiri-PST arm). There was no evidence of added benefit of PST on virological nonsuppression. There may not be scope for further reduction of virological nonsuppression below the low level achieved with Zvandiri care, particularly given that some nonsuppression is due to ART resistance rather than suboptimal adherence. Evidence of the extent of ART resistance in Zimbabwe is limited, but there are reasons to believe it is particularly high among adolescents. A study of 102 children and adolescents in Harare with virological failure in 2012 found that 68% of them had at least one clinically significant mutation [20]. This model integrates mental healthcare for adolescents into HIV care, as recommended in a recent review [21] and identified as a priority area by the Adolescent HIV Implementation Science Alliance [22]. Our finding that PST, as originally envisaged, was not appropriate or feasible for an adolescent population is in line with the literature. Adolescents have very limited agency to resolve their own problems and rely on others to help them [23]. An important element of PST is for the counsellor to help the client choose a problem that is both meaningful and within their power to change [9]. The extent of challenges that adolescents faced may have made it less feasible to help them to focus on “smaller” problems that were in their control. In our study, younger adolescents became tired over the course of a session and also had trouble brainstorming solutions within the time. The intervention was equally effective on mental health outcomes for younger adolescents as older ones, but this could be because the CATS adapted it towards “problem discussion therapy.” Caregivers have a role to play in adolescent mental health and HIV interventions [24]. In our trial, CATS pointed out that the minimal involvement of caregivers limited the capacity of the adolescent and CATS to resolve problems. The ZENITH trial in Zimbabwe showed improvement in HIV virological suppression of children aged 6 to 15, from a family-centred home-based support programme by lay workers [25,26]. This study supports previous evidence that young people gain fulfilment from being CATS [27], but it can also be challenging and emotionally draining, particularly when CATS are faced with problems that they do not have the resources or experience to handle. The needs of young peer supporters have been laid out in the TRUST framework [23], comprising Training, Referral pathways, Understanding the remit of their role, Supervision, and recognition that Talking helps. The strengths of the trial are that it was well powered with low intracluster correlation, the sample was representative of the whole country [7], follow-up was good (90.9% overall), and the qualitative evaluation enabled correct interpretation of the quantitative results. Limitations included that cost data were not available and that the mental health tools were validated in adult populations, not adolescents. The ways that the intervention was adapted may limit external application of the findings. Conclusions Virological nonsuppression is common among Zimbabwean adolescents with mental health problems living with HIV. This trial provides additional supporting evidence of the effect of Zvandiri on virological suppression. Training in counselling for peer supporters can have beneficial effects on mental health. We recommend that PST for adolescents should be less structured than the SMART plan for adults, with shorter sessions (especially for young adolescents) over a longer time frame. Counsellors should be trained to help clients identify problems that are within their power to affect. Creating a space for discussion and the sharing and discussion of problems, rather than solving them, should also be valued. Finally, ways to involve caregivers, such as family therapy approaches, should be explored. [END] [1] Url: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003887 (C) Plos One. "Accelerating the publication of peer-reviewed science." Licensed under Creative Commons Attribution (CC BY 4.0) URL: https://creativecommons.org/licenses/by/4.0/ via Magical.Fish Gopher News Feeds: gopher://magical.fish/1/feeds/news/plosone/