Intimate partners play an important role in chronic diseases. Despite the chronic disease burden increase in sub-Saharan Africa, very few culturally-relevant quantitative measures of intimate relationship functioning are available. We conducted an empirical investigation evaluating the psychometric properties of the South African Relationship Functioning Assessment (SARFA) assessing healthy relationship functioning in N = 150 community members (50% women; M age = 27.2 years) living in the Vulindlela area of KwaZulu-Natal, South Africa. Item development was based on prior qualitative research from two South African communities. All assessments were conducted in isiZulu, participants' primary language. An exploratory factor analysis was conducted on the initial 39-item measure. The best-fitting model consisted of one factor with 22 items. The SARFA's internal consistency was α = .94. Convergent validity was observed via significant positive associations (all rs ≥ .38, p < .001) between the SARFA's total score and measures of trust, emotional intimacy, constructive communication, sexual satisfaction, and relationship control (women only). Divergent validity was observed for women only. Encouraging initial psychometric properties of a culturally-relevant measure of relationship functioning in KwaZulu-Natal may have relevance to other communities and potential to be used in research involving couples and health in chronic disease-burdened communities.
South Africa has one of the highest rates of HIV/tuberculosis (TB) co-infection, and poor engagement in HIV/TB care contributes to morbidity and mortality. In South Africa, community health workers (CHWs) are tasked with re-engaging patients who have dropped out of HIV/TB care. CHWs have described substantial challenges with substance use (SU) and depression among their patients, while patients have described CHW stigma towards SU and depression as barriers to re-engagement in care. Yet, CHWs receive little-to-no training on SU or depression. Therefore, we piloted Siyakhana, a brief CHW training to reduce stigma related to SU and depression while improving skills for re-engaging these patients in HIV and/or TB care. This study evaluated the preliminary effectiveness (stigma towards SU and depression; clinical competence assessed via roleplay) and implementation (quantitative ratings of feasibility, acceptability, appropriateness, adoption; semi-structured written qualitative feedback) of Siyakhana among CHWs and supervisors (N = 17) at pre- and post-training assessments. SU stigma significantly decreased (F(1,16) = 18.94, p < 0.001, ηp2 = 0.54). Depression stigma was lower than SU stigma at both timepoints and did not significantly decrease after training. CHW clinical competency towards patients with SU/depression significantly improved (t(11) = -3.35, p = 0.007, d = 1.00). The training was rated as feasible, acceptable, appropriate, and likely to be adopted by CHWs and their supervisors. Nonjudgmental communication was commonly described as the most useful training component. Based on this pilot, the training is being refined and evaluated in a larger randomized stepped-wedge clinical trial.
Background: Community-based care (CBC), where care is delivered outside of the traditional health facility setting, has been proposed to narrow the mental health (MH) and substance use (SU) treatment gap in Africa. Objective: This scoping review aims to comprehensively summarize CBC models addressing adolescent and adult MH (depression, anxiety, trauma, suicidal behavior) and (non-tobacco) SU problems in Africa. Methods: We searched PsycINFO, Embase, Scopus, CINAHL, and Medline Ovid. Studies and protocols were included if they reported on CBC intervention's effects on MH or SU symptoms/ diagnoses, acceptability, feasibility, or patient engagement in care, regardless of whether the intervention itself was designed specifically for MH or SU. Results: Among 11,477 screened publications, 217 were eligible. Of the unique intervention studies (n = 206), CBC models were classified into the following approaches (non-mutually exclusive): psychotherapeutic (n = 144), social (n = 81), lifestyle/physical health (n = 55), economic (n = 26), and psychopharmacological (n = 2). While quantitative results suggest possible efficacy of CBC models, description of CBC location was often poor. Fewer interventions addressed suicidal behavior (n = 12), the needs of adolescents (n = 49), or used traditional healers or religious figures as providers (n = 3). Conclusion: Many CBC models have been tested on MH and SU in Africa and should be critically appraised and meta-analyzed in subsequent reviews, where possible.
INTRODUCTION: The use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (Botnar Research Centre for Child Health-European & Developing countries Clinical Trials Partnership)was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. METHODS: A cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 14 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants' understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. RESULTS: Cognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.3% (403/414, 95% CI: 95.3-98.7) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. CONCLUSION: Findings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.
COVID-19 , Child , Humans , Lesotho/epidemiology , Zambia/epidemiology , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Cross-Sectional Studies , Rapid Diagnostic Tests , Self-Testing
BACKGROUND: South Africa has deployed community health workers (CHWs) to support individuals to enter and stay in HIV/TB care. Although CHWs routinely encounter patients with mental health (particularly depression) and substance use (SU) conditions that impact their engagement in HIV/TB care, CHWs are rarely trained in how to work with these patients. This contributes to mental health and SU stigma among CHWs, a known barrier to patient engagement in care. Mental health and SU training interventions could reduce CHW stigma and potentially improve patient engagement in care, but evidence of the feasibility, acceptability, and preliminary effectiveness of these interventions is scarce. Therefore, we designed a hybrid type 2 effectiveness-implementation pilot trial to evaluate the implementation and preliminary effectiveness of a CHW training intervention for reducing depression and SU stigma in the Western Cape, South Africa. METHODS: This stepped wedge pilot trial will engage CHWs from six primary care clinics offering HIV/TB care. Clinics will be block randomized into three-step cohorts that receive the intervention at varying time points. The Siyakhana intervention involves 3 days of training in depression and SU focused on psychoeducation, evidence-based skills for working with patients, and self-care strategies for promoting CHW wellness. The implementation strategy involves social contact with people with lived experience of depression/SU during training (via patient videos and a peer trainer) and clinical supervision to support CHWs to practice new skills. Both implementation outcomes (acceptability, feasibility, fidelity) and preliminary effectiveness of the intervention on CHW stigma will be assessed using mixed methods at 3- and 6-month follow-up assessments. DISCUSSION: This trial will advance knowledge of the feasibility, acceptability, and preliminary effectiveness of a CHW training for reducing depression and SU stigma towards patients with HIV and/or TB. Study findings will inform a larger implementation trial to evaluate the longer-term implementation and effectiveness of this intervention for reducing CHW stigma towards patients with depression and SU and improving patient engagement in HIV/TB care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05282173. Registered on 7 March 2022.
BACKGROUND: Couple-based interventions (CBIs), despite strong efficacy in improving numerous HIV risk behaviors, are not widely available and have not been tested to improve women's antiretroviral therapy (ART) adherence. We examined barriers and facilitators to participation in a CBI based on cognitive behavioral couple therapy for women's ART adherence in KwaZulu-Natal, South Africa. METHODS: Semi-structured interviews were conducted with women with HIV (n = 15) and men of mixed HIV status (n = 15). Thematic analyses were guided by the Consolidated Framework for Implementation Research. RESULTS: Facilitators mostly related to the couple's relationship, including having an existing healthy relationship, men's desire to support their partners, and a potential opportunity for men's HIV disclosure. Barriers included a lack of understanding of how a CBI approach would be useful for women's ART adherence, sole focus on women if male partners were also living with HIV, and men's lack of prior HIV status disclosure to female partners. CONCLUSION: Findings indicate that relationship context and the male partner's HIV status need to be addressed during recruitment, enrolment, and during the intervention to promote uptake.
HIV Infections , Sexual Partners , Humans , Male , Female , Sexual Partners/psychology , South Africa , Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/psychology , Patient Compliance
INTRODUCTION: The prevalence of type 2 diabetes mellitus (T2DM) and associated morbidity and mortality are increasing in sub-Saharan Africa (SSA). To facilitate access to quality care and improve treatment outcomes, there is a need for innovative community care models and optimized use of non-physician healthcare workers bringing diagnosis and care closer to patients' homes. AIM: We aimed to describe with a scoping review different models of community-based care for non-pregnant adults with T2DM in SSA, and to synthesize the outcomes in terms of engagement in care, blood sugar control, acceptability, and end-organ damage. We further aimed to critically appraise the different models of care and compare community-based to facility-based care if data were available. METHODS: We searched Medline, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Scopus, supplemented with backward and forward citation searches. We included cohort studies, randomized trials and case-control studies that reported on non-pregnant individuals diagnosed with T2DM in SSA, who received a substantial part of care in the community. Only studies which reported at least one of our outcomes of interest were included. A narrative analysis was done, and comparisons made between community-based and facility-based models, where within-study comparison was reported. RESULTS: We retrieved 5,335 unique studies, four of which met our inclusion criteria. Most studies were excluded because interventions were facility-based; community care interventions described in the studies were only add-on features of a primarily facility-based care; and studies did not report outcomes of interest. The included studies reported on a total of 383 individuals with T2DM. Three different community care models were identified. 1) A community-initiated model where diagnosis, treatment and monitoring occurred primarily in the community. This model reported a higher linkage and engagement in care at 9 months compared to the corresponding facility model, but only slight reductions of average blood glucose levels at six months compared to baseline. 2) A facility-originated community model where after treatment initiation, a substantial part of follow-up was offered at community level. Two studies reported such a model of care, both had as core component home-delivery of medication. Acceptability of this approach was high. But neither study found improved T2DM control when compared to facility care 3) An eHealth model with high acceptability scores for both patients and care providers, and an absolute 1.76% reduction in average HbA1c levels at two months compared to baseline. There were no reported outcomes on end-organ damage. All four studies were rated as being at high risk for bias. CONCLUSION: Evidence on models of care for persons with T2DM in SSA where a substantial part of care is shifted to the community is scant. Whereas available literature indicates high acceptability of community-based care, we found no conclusive data on their effectiveness in controlling blood sugar and preventing complications. Evidence from larger scale studies, ideally randomized trials with clinically relevant endpoints is needed before roll-out of community-based T2DM care can be recommended in SSA.
Diabetes Mellitus, Type 2 , Humans , Adult , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/therapy , Blood Glucose , Africa South of the Sahara/epidemiology , Cohort Studies , Case-Control Studies
The sudden emergence of the coronavirus disease 2019 (COVID-19) had a devastating impact on health systems and population health globally. To combat the spread of COVID-19, countries enacted guidelines and safety measures, including testing, contact tracing, and quarantine. It was unclear the extent to which uptake of COVID-19 testing and other health initiatives would be accepted in countries with a history of dealing with widespread communicable disease transmission such as HIV or Tuberculosis. The objective of this study was to understand and compare the facilitators and barriers to COVID-19 testing at hospital sites in two rural communities in Lesotho and community spaces (referred to as hubs) in one urban community in Zambia during active phases of COVID-19 pandemic. Individual interviews and focus group discussions (FGDs) were held during March-October 2021 to explore facilitators and barriers to COVID-19 testing. FGDs with 105 community members and health care workers, and 16 individual interviews with key informants and four mystery shoppers were conducted across the two countries. In Zambia, four mystery shopper observations, and eight hub observations were also conducted. Individual country codebooks were developed and combined; thematic analyses were then conducted using the combined codebook. Findings were compared across the two countries, and most were consistent across the two countries. Two primary themes emerged that related to both barriers and facilitators: (1) structural conditions; (2) social implications and attitudes. The structural conditions that operated as barriers in both countries included public health isolation measures and misinformation. In Lesotho, the cost of tests was an additional barrier. The only structural facilitators were in Zambia where the community hubs were found to be accessible and convenient. The social implication barriers related to fear of isolation, stigma, and mental health implications because of quarantine, perceived pain of the test, and compromised privacy. Social facilitators that led to people testing included experiencing COVID-19 firsthand and knowing people who had died because of COVID-19. Across both countries, primary barriers and facilitators to COVID-19 related to structural conditions and social implications and attitudes. Public health measures can be at odds with social and economic realities; pandemic response should balance public health control and the socio-economic needs. Data from Zambia revealed that community-based settings have the potential to increase uptake of testing services. Community-based campaigns to normalize and reduce stigma for COVID-19 testing services are needed.
This study explored how sexual or gender minority (SGM) status influenced substance use (SU) treatment outcomes in a predominantly African American and unemployed sample of people with HIV. N = 60 participants were enrolled in an abstinence-focused inpatient SU treatment center, followed by outpatient treatment sessions. At 12-months follow-up, the survival rate (i.e. those who did not reuse substances) was 37.6% (non-SGM group) vs. 4.8% (SGM group). The impact of SGM status on reuse was .54 log odds, p = .11, which translates to a 71.8% increase in the hazard of reusing substances for SGM vs. non-SGM individuals. For both groups, frequency of reuse remained stable and problems associated with SU decreased over time. Results suggest a potentially clinically relevant finding that SGM individuals have possible heigh-tened risk of SU after a mixed inpatient-outpatient program. ClinicalTrials.gov trial registration number: NCT01351454.
INTRODUCTION: HIV programmes across many countries in Africa have recently transitioned people living with HIV from efavirenz (EFV)- to dolutegravir (DTG)-containing antiretroviral therapy (ART). As both drugs are associated with neuropsychiatric adverse effects, this study assessed the mental health and HIV/ART-associated symptoms of people living with HIV before and after transition to DTG. METHODS: The prospective DO-REAL cohort enrolled people starting DTG-based ART in Lesotho from February to December 2020. For this analysis within DO-REAL, we included adults changing from tenofovir disoproxil fumarate (TDF)/lamivudine (3TC)/EFV to TDF/3TC/DTG within first-line therapy. At transition and 16 weeks thereafter, participants completed the Patient Health Questionnaire-9 (PHQ-9; depression screening), the 12-item Short-Form Health Survey (SF-12; mental and physical health), and a modified HIV Symptom Index (mHSI; HIV/ART-related symptoms). We also assessed weight change. We used McNemar tests with Bonferroni corrections to assess binary outcomes. CLINICALTRIALS: gov: NCT04238767. RESULTS: Among 1228 participants, 1131 completed follow-up. Of these, 60.0% were female, the median age was 46 years (interquartile range [IQR] 38-55), and the median time taking ART was 5.7 years (IQR 3.5-8.9). No change was observed for weight or overall PHQ-9 or SF-12 outcomes. However, three mHSI items decreased at follow-up: 'feeling sad/down/depressed' (bothered 6.0% vs. 3.3% of participants at least 'a little' before vs. after transition; adjusted p = 0.048); 'feeling nervous/anxious' (7.4% vs. 3.4%; adjusted p = 0.0009); and 'nightmares, strange/vivid dreams' (6.3% vs. 3.5%; adjusted p = 0.027). Individual PHQ-9 or SF-12 items also improved. Being symptom free across all measures increased from 5.1% to 11.4% (p < 0.0001). CONCLUSIONS: We observed no negative impacts and potential moderate improvements with DTG, providing further support for the rollout of DTG.
Anti-HIV Agents , HIV Infections , Adult , Humans , Female , Middle Aged , Male , HIV Infections/drug therapy , Anti-HIV Agents/adverse effects , Prospective Studies , Lesotho , Self Report , Oxazines/therapeutic use , Benzoxazines/adverse effects , Lamivudine/therapeutic use , Heterocyclic Compounds, 3-Ring/adverse effects , Tenofovir/adverse effects , Outcome Assessment, Health Care
Approximately one-third of people living with human immunodeficiency virus (HIV) in South Africa (SA) present to HIV care with unhealthy alcohol use (UA); depression is highly prevalent among this population. Internalized HIV and UA stigma have been associated with greater depressive symptoms when examined in isolation. Yet, prior research has rarely examined how internalized HIV and UA stigmas together relate to depressive symptoms and related outcomes. This study examined how internalized stigma around HIV and UA together are associated with depressive symptoms, related social and work/school impairments, and cognitive and behavioral processes associated with depression (activation, rumination). Data were drawn from the baseline assessment (N=64) of a behavioral intervention trial focused on improving UA and ART adherence. Participants were categorized based on combined internalized alcohol and HIV stigma scores (low vs. high on each). Regression models examined associations between each stigma category with the following outcomes: depressive symptoms, work/school impairment, and activation/rumination Compared to participants low in both stigmas, being high in both HIV and alcohol internalized stigmas was significantly associated with greater depressive symptoms (B = .38, p = .01), lower activation (B = -4.19, p = .04), greater rumination (B = 5.72, p = .02), and greater work/school impairment (B = 3.94, p = .01). High internalized alcohol (B = -5.97, p = .009) or HIV stigma (B = -5.25, p = .02) alone was significantly associated with lower activation. This study provides preliminary understanding how multiple layers of internalized stigma together relate to psychosocial outcomes among people living with HIV (PLWH) in SA.
Background: South Africa currently has the greatest number of people with HIV globally. The country has not yet met its 95-95-95 goals, with different gaps in the HIV care cascade for women and men. This paper reports on a protocol to pilot test a couple-based intervention designed to improve women's antiretroviral therapy (ART) adherence and men's engagement in care in heterosexual couples living in the Vulindlela area of KwaZulu-Natal, South Africa. Study goals are two-fold: (1) assess the acceptability, feasibility, and fidelity of the experimental intervention, START Together, and (2) collect efficacy data on START Together for women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning. Methods: Women (N = 20) who were not engaged with ART adherence (defined via self-reported ART difficulties, record of missed clinic visits, or viral non-suppression) are the target patients; male partners are not required to know or disclose their HIV status to be part of the study. Couples are randomized 1:1 to the experimental treatment (START Together) or treatment as usual (referrals to the local clinic to support ART adherence or any other HIV-related care). START Together is a 5-session intervention based in cognitive-behavioral couple therapy, which is a skill-based intervention focusing on communication and problem-solving skills, and Life Steps, a problem-solving intervention identifying barriers and solutions to medication adherence. Couples are assessed at baseline, post-treatment (8 weeks post-randomization), and follow-up (12 weeks post-randomization). Conclusion: This study will provide preliminary implementation and efficacy data on whether this novel approach has potential to improve women and men's HIV and healthcare-related needs.
Human immunodeficiency virus (HIV) and problematic alcohol use are two ongoing and interconnected epidemics in South Africa, with untreated problematic alcohol use associated with poorer HIV treatment outcomes and disease progression. A lack of trained mental health providers is a primary barrier to increasing access to evidence-based treatment in this setting. To address this gap, we integrated evidence-based intervention components for problematic alcohol use and antiretroviral therapy (ART) adherence, adapted for lay provider delivery in an HIV primary care setting in Cape Town, South Africa. The intervention, locally termed "Khanya" in isiXhosa, which means glow, direction, or light, comprises Life Steps adherence counseling, motivational interviewing, behavioral activation, and relapse prevention, including mindfulness-based relapse prevention components. In this case series, we present a detailed description of the intervention and provide three clinical cases of individuals who received the Khanya intervention to showcase necessary clinical adaptations and the supervision needed for optimal treatment delivery, flexibility in intervention delivery, and overall successes and challenges. We present descriptive data on alcohol use and ART adherence outcomes for the cases to supplement the narrative discussion. Successes of intervention delivery included participant uptake of mindfulness skills, reductions in alcohol use despite varying levels of motivation, and interventionist mastery over various clinical skills. Challenges included delivering the intervention within the allotted time and the strong influence of substance-using social networks. Overall, a pragmatic approach to intervention delivery was necessary, as was ongoing support for the interventionist to promote fidelity to both treatment components and therapeutic skills. Trial registration: ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.
BACKGROUND: South Africa has the highest number of people with HIV (PWH) globally and a significant burden of co-occurring substance use disorder (SUD). Health care worker (HCW) stigma towards SUD is a key barrier to HIV care engagement among PWH with SUD. Support from peers-individuals with lived experience of SUD-may be a promising solution for addressing SUD stigma, while also improving engagement in HIV care. We evaluated the perceived acceptability of integrating a peer role into community-based HIV care teams as a strategy to address SUD stigma at multiple levels and improve patient engagement in HIV care. METHODS: Patients and stakeholders (N = 40) were recruited from publicly-funded HIV and SUD organizations in Cape Town, South Africa. We conducted a quantitative assessment of stigma among stakeholders using an adapted Social Distance Scale (SDS) and patient perceptions of working with a peer, as well as semi-structured interviews focused on experiences of SUD stigma, acceptability of a peer model integrated into community-based HIV care, and potential peer roles. RESULTS: On the SDS, 75% of stakeholders had high stigma towards a patient with SUD, yet 90% had low stigma when in recovery for at least 2 years. All patients endorsed feeling comfortable talking to someone in recovery and wanting them on their HIV care team. Three main themes emerged from the qualitative data: (1) patient-reported experiences of enacted SUD and HIV stigmas were common and impacted HIV care engagement; (2) both patients and stakeholders considered a peer model highly acceptable for integration into HIV care to support engagement and address SUD stigma; and (3) patients and stakeholders identified both individual-level and systems-level roles for peers, how peers could work alongside other providers to improve patient care, and key characteristics that peers would need to be successful in these roles. CONCLUSIONS: Findings from this formative work point to the promise of a peer model for reducing SUD stigma among patients and HCWs within community-based HIV care teams in SA.
HIV Infections , Substance-Related Disorders , HIV Infections/therapy , Humans , Qualitative Research , Social Stigma , South Africa , Substance-Related Disorders/therapy
Little is known about gender effects of alcohol and drug use (AOD) among people living with HIV (PLWH) in resource-limited settings. Using multilevel models, we tested whether gender moderated the effect of Khanya, a cognitive-behavioral therapy-based intervention addressing antiretroviral (ART) adherence and AOD reduction. We enrolled 61 participants from HIV care and examined outcomes at 3- and 6-months compared to enhanced treatment as usual (ETAU). Gender significantly moderated the effect of Khanya on ART adherence (measured using electronically-monitored and biomarker-confirmed adherence), such that women in Khanya had significantly lower ART adherence compared to men in Khanya; no gender differences were found for AOD outcomes. Exploratory trajectory analyses showed men in Khanya and both genders in ETAU had significant reductions in at least one AOD outcome; women in Khanya did not. More research is needed to understand whether a gender lens can support behavioral interventions for PLWH with AOD.Trial registry ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.
HIV Infections , Substance-Related Disorders , Anti-Retroviral Agents/therapeutic use , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Male , Medication Adherence , South Africa/epidemiology , Substance-Related Disorders/complications , Substance-Related Disorders/epidemiology
INTRODUCTION: To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving. METHODS: The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences. EXPECTED OUTCOMES: Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving. TRIAL REGISTRATION: The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020).
Anti-HIV Agents , HIV Infections , Adult , Anti-HIV Agents/therapeutic use , Delivery of Health Care , HIV Infections/drug therapy , Humans , Lesotho , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Viral Load
BACKGROUND: Despite HIV and problematic drinking often co-occurring in South Africa (SA), limited research has examined how HIV stigma relates to alcohol outcomes, how alcohol stigma relates to HIV outcomes, and moderators of these associations. This study examined the intersection of HIV and alcohol stigmas on HIV and alcohol outcomes, and the role of avoidant behavior in moderating these relationships in SA. METHODS: We assessed biomarker-verified measures of antiretroviral therapy (ART) adherence, HIV viral load (VL), and alcohol consumption, and self-reported measures of internalized HIV/alcohol stigmas, avoidant behavior, ART adherence, and problematic drinking-alcohol use that will likely lead to health or other problems-cross-sectionally among people with HIV (PWH) and problematic drinking (N = 64). We conducted regression analyses with interaction terms. FINDINGS: A significant relationship was found between internalized alcohol stigma and VL suppression, with higher levels of alcohol stigma associated with a lower likelihood of suppression (OR=1.68, 95%CI[1.11-2.65], p = .02). Avoidance significantly moderated the relationship between internalized HIV stigma and problematic drinking; higher HIV stigma was associated with lower problematic drinking only at low levels of avoidance (b(SE)= -1.92(.85), p = .03). CONCLUSIONS: This study is the first to examine associations between HIV and alcohol stigmas, avoidance, and both HIV and alcohol outcomes in SA. Findings contribute to our understanding of how alcohol stigma relates to biological HIV outcomes, and the role of avoidance in the relationship between internalized HIV stigma and problematic drinking. Findings may inform future clinical interventions aiming to address the impact of stigma on HIV treatment outcomes and alcohol use among PWH in SA.
HIV Infections , Medication Adherence , Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , Humans , Social Stigma , South Africa/epidemiology
Harmful alcohol consumption can significantly compromise adherence to antiretroviral therapy (ART). Prior research has identified aggregate relationships between alcohol use and ART non-adherence, largely relying on concurrent assessment of these domains. There is relatively limited evidence on more nuanced day-level associations between alcohol use and ART non-adherence, despite potentially important clinical implications. We recruited adults with HIV treatment adherence challenges and harmful alcohol use (n = 53) from HIV care in South Africa. We examined relationships between alcohol use and same and next day ART adherence, accounting for the role of weekends/holidays and participant demographics, including gender. Results demonstrated that ART adherence was significantly worse on weekend/holiday days. Next day adherence was significantly worse in the context of weekend alcohol use and among men. These results suggest the importance of tailoring intervention strategies to support ART adherence during weekend drinking and for men engaged in heavy episodic drinking.
Alcoholism , Anti-HIV Agents , HIV Infections , Adult , Alcohol Drinking/epidemiology , Alcoholism/drug therapy , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Male , Medication Adherence , South Africa/epidemiology
There is a need for parsimonious behavioral interventions to support HIV and substance use treatment outcomes for low-income, Black/African American individuals living with HIV. This randomized clinical trial (N = 61) evaluated Act Healthy (AH), an integrated behavioral intervention to reduce substance use and improve medication adherence, compared to supportive counseling (SC) plus Life-Steps medication adherence counseling on substance use, craving, adherence-related outcomes, and depression over one year. Participants in AH had significantly steeper decreases in cravings compared to SC, but no significant differences in substance use. Across both groups, there was a significant increase in probability of being on antiretroviral therapy (ART) (86% on ART at 12 months vs. 56% at baseline), and a significant decrease in medication nonadherence. Findings provide preliminary support for an intervention to reduce cravings and strategies to improve ART use in a hard-to-reach, vulnerable population at high risk for poor treatment outcomes and ongoing HIV transmission. TRIAL REGISTRATION: ClinicalTrials.gov trial registration number: identifier: NCT01351454. Retrospectively registered on May 10, 2011.
Acquired Immunodeficiency Syndrome , HIV Infections , Substance-Related Disorders , Black or African American , HIV Infections/drug therapy , Humans , Medication Adherence
Interventions led by peer recovery specialists (PRSs) have rapidly expanded in response to a global shortage of access to substance use treatment. However, there is a lack of guidance on how to incorporate PRSs' lived experience into the delivery of evidence-based interventions (EBIs). Moreover, few resources exist to assess fidelity that integrate both content fidelity, peer competence, and incorporation of lived experience (i.e., PRS role fidelity). This study aimed to: (1) describe a novel PRS fidelity monitoring approach to assess both content and PRS role fidelity; (2) compare independent rater and PRS-self-reported content fidelity; (3) examine associations between content and PRS role fidelity; and (4) assess whether the PRS role fidelity was associated with substance use at post-treatment. This study was conducted across two PRS-led behavioral intervention trials conducted in global resource-limited settings: Baltimore City, US, and Khayelitsha, South Africa. A significant difference was found between PRS- and independent rater content fidelity in both interventions, with PRSs reporting significantly higher content fidelity in both sites. PRS role and content fidelity were not significantly correlated, suggesting greater adherence to the PRS role is not associated with lower adherence to structured EBI content. PRS role fidelity was not significantly associated with substance use at post-treatment. This study provides an important step towards understanding how to assess PRS role fidelity in the context of EBIs for underserved individuals with SUD that also incorporates their lived experience.
