"The peace that I wanted, I got": Qualitative insights from patient experiences of SMART DAPPER interventions for major depression and traumatic stress disorders in Kenya.

SMART DAPPER is an implementation science study responding to mental health treatment gaps for depression and trauma-related disorders in Sub-Saharan Africa (SSA). We report on patient experiences in a study using a Sequential, Multiple Assignment Randomized Trial (SMART) design to test first and second line non-specialist treatment using psychotherapy (Interpersonal Psychotherapy [IPT] or medication (fluoxetine [FLX]), integrated within public sector primary care in western Kenya. An embedded qualitative study conducted in-depth interviews (n = 17) and three (n = 3) focus group discussions with participants (May to October 2021). Audio-recorded interviews were transcribed and translated into English; we deductively and inductively analyzed transcripts guided by grounded theoretical approaches and content analysis. We drew on the health belief model and socio-ecological framework to present findings, including perceived severity (motivations for taking part in the intervention), impacts of the intervention at the individual, interpersonal, and community and health systems levels as well as barriers and facilitators. Participants discussed family and marital conflict, loss of a child, loss of income or a job, and traumatic events such as a death or illness. Impacts at the individual level included reduced headaches, improved appetite and weight management, increased energy, improved sleep, better self-efficacy, and improved concentration, which was reported to lead to increased economic opportunities. At the interpersonal level, participants noted a reduction in conflict, better conflict management and resolution, increased harmony with family and community members, and improved relationships with their partners and children. Perceived challenges included balancing the intervention with livelihoods, preference for traditional medicines, actual or anticipated side effects with medication (FLX), mental health stigma, major life events, and perceived inadequate counseling and challenges with providers. The findings demonstrate the potential of the SMART DAPPER intervention for depression and trauma-related disorder treatments and underscore the challenges and barriers that must be addressed when scaling similar interventions. Trial registration: ClinicalTrials.gov identifier: NCT03466346.

Defining a screening tool for post-traumatic stress disorder in East Africa: a penalized regression approach.

Background: Scalable PTSD screening strategies must be brief, accurate and capable of administration by a non-specialized workforce. Methods: We used PTSD as determined by the structured clinical interview as our gold standard and considered predictors sets of (a) Posttraumatic Stress Checklist-5 (PCL-5), (b) Primary Care PTSD Screen for the DSM-5 (PC-PTSD) and, (c) PCL-5 and PC-PTSD questions to identify the optimal items for PTSD screening for public sector settings in Kenya. A logistic regression model using LASSO was fit by minimizing the average squared error in the validation data. Area under the receiver operating characteristic curve (AUROC) measured discrimination performance. Results: Penalized regression analysis suggested a screening tool that sums the Likert scale values of two PCL-5 questions-intrusive thoughts of the stressful experience (#1) and insomnia (#21). This had an AUROC of 0.85 (using hold-out test data) for predicting PTSD as evaluated by the MINI, which outperformed the PC-PTSD. The AUROC was similar in subgroups defined by age, sex, and number of categories of trauma experienced (all AUROCs>0.83) except those with no trauma history- AUROC was 0.78. Conclusion: In some East African settings, a 2-item PTSD screening tool may outperform longer screeners and is easily scaled by a non-specialist workforce.

Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial.

BACKGROUND: HIV-positive women suffer a high burden of mental disorders due in part to gender-based violence (GBV). Comorbid depression and posttraumatic stress disorder (PTSD) are typical psychiatric consequences of GBV. Despite attention to the HIV-GBV syndemic, few HIV clinics offer formal mental healthcare. This problem is acute in sub-Saharan Africa, where the world's majority of HIV-positive women live and prevalence of GBV is high. METHODS AND FINDINGS: We conducted a randomized controlled trial at an HIV clinic in Kisumu, Kenya. GBV-affected HIV-positive women with both major depressive disorder (MDD) and PTSD were randomized to 12 sessions of interpersonal psychotherapy (IPT) plus treatment as usual (TAU) or Wait List+TAU. Nonspecialists were trained to deliver IPT inside the clinic. After 3 months, participants were reassessed, and those assigned to Wait List+TAU were given IPT. The primary outcomes were diagnosis of MDD and PTSD (Mini International Neuropsychiatric Interview) at 3 months. Secondary outcomes included symptom measures of depression and PTSD, intimate partner violence (IPV), and disability. A total of 256 participants enrolled between May 2015 and July 2016. At baseline, the mean age of the women in this study was 37 years; 61% reported physical IPV in the past week; 91% reported 2 or more lifetime traumatic events and monthly income was 18USD. Multilevel mixed-effects logistic regression showed that participants randomized to IPT+TAU had lower odds of MDD (odds ratio [OR] 0.26, 95% CI [0.11 to 0.60], p = 0.002) and lower odds of PTSD (OR 0.35, [0.14 to 0.86], p = 0.02) than controls. IPT+TAU participants had lower odds of MDD-PTSD comorbidity than controls (OR 0.36, 95% CI [0.15 to 0.90], p = 0.03). Linear mixed models were used to assess secondary outcomes: IPT+TAU participants had reduced disability (-6.9 [-12.2, -1.5], p = 0.01), and nonsignificantly reduced work absenteeism (-3.35 [-6.83, 0.14], p = 0.06); partnered IPT+TAU participants had a reduction of IPV (-2.79 [-5.42, -0.16], p = 0.04). Gains were maintained across 6-month follow-up. Treatment group differences were observed only at month 3, the time point at which the groups differed in IPT status (before cross over). Study limitations included 35% attrition inclusive of follow-up assessments, generalizability to populations not in HIV care, and data not collected on TAU resources accessed. CONCLUSIONS: IPT for MDD and PTSD delivered by nonspecialists in the context of HIV care yielded significant improvements in HIV-positive women's mental health, functioning, and GBV (IPV) exposure, compared to controls. TRIAL REGISTRATION: Clinical Trials Identifier NCT02320799.

Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.

BACKGROUND: Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN: We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION: The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.

PrEP and the syndemic of substance use, violence, and HIV among female and male sex workers: a qualitative study in Kisumu, Kenya.

INTRODUCTION: Female and male sex workers experience heightened vulnerability to HIV and other health harms that are compounded by substance use, physical and sexual violence, and limited access to health services. In Kisumu, Kenya, where sex work is widespread and substance use is a growing public health concern, offering pre-exposure prophylaxis (PrEP) for HIV prevention could help curtail the HIV epidemic. Our study examines "syndemics," or mutually reinforcing epidemics of substance use, violence and HIV, in relation to PrEP acceptability and feasibility among female and male sex workers in Kenya, one of the first African countries to approve PrEP for HIV prevention. METHODS: From 2016 to 2017, sex workers in Kisumu reporting recent alcohol or drug use and experiences of violence participated in qualitative interviews on HIV risk and perspectives on health service needs, including PrEP programming. Content analysis identified themes relating to PrEP knowledge, acceptability, access challenges and delivery preferences. RESULTS: Among 45 female and 28 male sex workers, median age was 28 and 25 respectively. All participants reported past-month alcohol use and 91% of women and 82% of men reported past-month drug use. Violence was pervasive, with most women and men reporting past-year physical (96% women, 86% men) and sexual (93% women, 79% men) violence. Concerning PrEP, interviews revealed: (1) low PrEP knowledge, especially among women; (2) high PrEP acceptability and perceived need, particularly within syndemic contexts of substance use and violence; and (3) preferences for accessible, non-stigmatizing PrEP delivery initiatives designed with input from sex workers. CONCLUSIONS: Through a syndemic lens, substance use and violence interact to increase HIV vulnerability and perceived need for PrEP among female and male sex workers in Kisumu. Although interest in PrEP was high, most sex workers in our sample, particularly women, were not benefiting from it. Syndemic substance use and violence experienced by sex workers posed important barriers to PrEP access for sex workers. Increasing PrEP access for sex workers will require addressing substance use and violence through integrated programming.

Perspectives on biomedical HIV prevention options among women who inject drugs in Kenya.

Due to heightened vulnerability to HIV from frequent engagement in sex work and overlapping drug-using and sexual networks, women who inject drugs should be a high priority population for pre-exposure prophylaxis (PrEP) and other biomedical HIV prevention tools. Kenya is one of the first African countries to approve oral PrEP for HIV prevention among "key populations," including people who inject drugs and sex workers. The objective of this study was to explore preferences and perceived challenges to PrEP adoption among women who inject drugs in Kisumu, Kenya. We conducted qualitative interviews with nine HIV-uninfected women who inject drugs to assess their perceptions of biomedical HIV interventions, including oral PrEP, microbicide gels, and intravaginal rings. Despite their high risk and multiple biomedical studies in the region, only two women had ever heard of any of these methods. All women were interested in trying at least one biomedical prevention method, primarily to protect themselves from partners who were believed to have multiple other sexual partners. Although women shared concerns about side effects and product efficacy, they did not perceive drug use as a significant deterrent to adopting or adhering to biomedical prevention methods. Beginning immediately and continuing throughout Kenya's planned PrEP rollout, efforts are urgently needed to include the perspectives of high risk women who use drugs in biomedical HIV prevention research and programing.

Jaboya ("Sex for Fish"): A Qualitative Analysis of Contextual Risk Factors for Extramarital Partnerships in the Fishing Communities in Western Kenya.

Extramarital partnerships exacerbate high HIV prevalence rates in many communities in sub-Saharan Africa. We explored contextual risk factors and suggested interventions to reduce extramarital partnerships among couples in the fishing communities on Lake Victoria, Kenya. We conducted 12 focus group discussions with 9-10 participants each (N = 118) and 16 in-depth interviews (N = 16) with fishermen and their spouses. Couples who participated were consented and separated for simultaneous gender-matched discussions/interviews. Interview topics included courtship and marriage, relationship and sexual satisfaction, extramarital relationships and how to intervene on HIV risks. Coding, analysis, and interpretation of the transcripts followed grounded theory tenets that allow analytical themes to emerge from the participants. Our results showed that extramarital partnerships were perceived to be widespread and were attributed to factors related to sexual satisfaction such as women needing more foreplay before intercourse, discrepancies in sexual desire, and boredom with the current sexual repertoire. Participants also reported that financial and sociophysical factors such as family financial support and physical separation, contributed to the formation of extramarital partnerships. Participants made suggestions for interventions that reduce extramarital partnerships to minimize HIV risks at the community, couple, and individual level. These suggestions emphasized improving community education, spousal communication, and self-evaluation for positive behavior change. Future studies can draw upon these findings as a basis for designing community-owned interventions that seek to reduce community-level HIV risk through a reduction in the number of sexual partners.

Brief Report: Sexual Violence Against HIV-Positive Women in the Nyanza Region of Kenya: Is Condom Negotiation an Instigator?

For people living with HIV, exposure to sexual violence (SV) is associated with decreased adherence to antiretroviral medication, a primary predictor of their survival. Identification of risk factors for SV is a pressing issue in sub-Saharan Africa, where the global majority of HIV-positive women live and the prevalence of SV against women is high. We used qualitative data to examine SV against HIV-positive women enrolled in HIV care in Kenya. Respondents identified husbands as perpetrators of SV in the context of women's efforts to use condoms as directed by HIV care providers.

Collaborative Interpersonal Psychotherapy for HIV-Positive Women in Kenya: A Case Study From the Mental Health, HIV and Domestic Violence (MIND) Study.

We examine the efficacy of nonspecialists delivering interpersonal psychotherapy (IPT) to HIV-positive (HIV+) women. We describe a case in which local personnel without prior mental health training delivered IPT for the treatment of depression and posttraumatic stress disorder in an HIV+ woman who reported experiencing gender-based violence and was enrolled in HIV care at the Family AIDS, Care, Education and Services program in Kisumu, Kenya.

Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial.

BACKGROUND: Mental disorders are the leading global cause of years lived with disability; the majority of this burden exists in low and middle income countries (LMICs). Over half of mental illness is attributable to depression and anxiety disorders, both of which have known treatments. While the scarcity of mental health care providers is recognized as a major contributor to the magnitude of untreated disorders in LMICs, studies in LMICs find that evidence-based treatments for depression and anxiety disorders, such as brief, structured psychotherapies, are feasible, acceptable and have strong efficacy when delivered by local non-specialist personnel. However, most mental health treatment studies using non-specialist providers in LMICs deploy traditional efficacy designs (T1) without the benefit of integrated mental health treatment models shown to succeed over vertical interventions or methods derived from new implementation science to speed policy change. Here, we describe an effectiveness-implementation hybrid study that evaluates non-specialist delivery of mental health treatment within an HIV clinic for HIV-positive (HIV+) women affected by gender- based violence (GBV) (HIV+ GBV+) in the Nyanza region of Kenya. METHODS/DESIGN: In this effectiveness-implementation hybrid type I design, 200 HIV+ women with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD) who are receiving care at a Family AIDS Care Education and Services (FACES)-supported clinic in Kisumu, Kenya will be randomized to: (1) interpersonal psychotherapy (IPT) + treatment as usual (TAU) or (2) TAU, both delivered within the HIV clinic. IPT will consist of 12 weekly 60-minute individual IPT sessions, delivered by non-specialists trained to provide IPT. Primary effectiveness outcomes will include MDD and PTSD diagnosis on the Mini International Diagnostic Interview (MINI). Primary implementation outcomes will include treatment cost-benefit, acceptability, appropriateness, feasibility and fidelity of the IPT delivery within an HIV clinic. DISCUSSION: This trial leverages newly defined effectiveness-implementation hybrid designs to gather data on mental health treatment implementation within an HIV care clinic, while testing the effectiveness of an evidence-based treatment for use with a large underserved population (HIV+ GBV+ women) in Kenya. CLINICAL TRIALS IDENTIFIER: NCT02320799, registered on 9 September 2014.

A Qualitative Study of Substance use during Pregnancy: Implications for Reproductive Healthcare in Western Kenya.

Women who use alcohol and drugs are often in their childbearing years, creating a need for integrated substance abuse and reproductive health services. However, our understanding of the social context and drivers of substance use during pregnancy, particularly in developing countries, is limited and largely unaddressed in clinical care. Our qualitative research explored the reproductive health of women of childbearing age who inject drugs and its implications for healthcare in Kisumu, Kenya. We used in-depth, semi-structured qualitative interviews with 17 women who inject drugs to explore reproductive health topics including knowledge, practices, and clinical interactions related to substance use during pregnancy. All but one woman had a prior pregnancy and two were pregnant during our study. Alcohol and drug use was prevalent throughout pregnancy, often described as a coping mechanism for stress. Women received mixed advice from family and social contacts regarding alcohol use during pregnancy, leading to differing perceptions of its health effects. Healthcare providers infrequently screened women for alcohol or drug use. Our analysis highlights the need for culturally appropriate alcohol and drug screening and counseling to be included in integrated reproductive health services in western Kenya.

Evidence of injection drug use in Kisumu, Kenya: Implications for HIV prevention.

BACKGROUND: Injection drug use is increasingly contributing to the HIV epidemic across sub-Saharan Africa. This paper provides the first descriptive analysis of injection drug use in western Kenya, where HIV prevalence is already highest in the nation at 15.1%. METHODS: We draw on quantitative data from a study of injection drug use in Kisumu, Kenya. We generated descriptive statistics on socio-demographics, sexual characteristics, and drug-related behaviors. Logistic regression models were adjusted for sex to identify correlates of self-reported HIV positive status. RESULTS: Of 151 participants, mean age was 28.8 years, 84% (n = 127) were male, and overall self-reported HIV prevalence reached 19.4%. Women had greater than four times the odds of being HIV positive relative to men (Odds Ratio [OR] 4.5, CI: 1.7, 11.8, p = .003). Controlling for sex, ever experiencing STI symptoms (Adjusted Odds ratio [AOR] 4.6, 95% CI 1.7, 12.0, p = .002) and sharing needles or syringes due to lack of access (AOR 3.6, 95% CI 1.2, 10.5, p = .02) were significantly associated with HIV positive status. Lower education (AOR 2.3, 95% CI 0.9, 5.6, p=.08), trading sex for drugs (AOR 2.8, 95% CI 0.9, 8.8, p = .08), being injected by a peddler (AOR 2.9, 95% CI 1.0, 8.5, p = .05), and injecting heroin (AOR 2.3, 95% CI 1.0, 5.7, p = .06), were marginally associated with HIV. CONCLUSIONS: This exploratory study identified patterns of unsafe drug injection and concurrent sexual risk in western Kenya, yet few resources are currently available to address addiction or injection-related harm. Expanded research, surveillance, and gender sensitive programming are needed.