scholarly journals The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Phepo Mogoba ◽  
Maia Lesosky ◽  
Allison Zerbe ◽  
Joana Falcao ◽  
Claude Ann Mellins ◽  
...  

Abstract Background Adolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and individual-level barriers to retention in HIV care, uptake of ART, and achievement of viral suppression (VS), underscoring an urgent need for multi-component interventions to address these challenges. This cluster-randomized control trial (cRCT) aims to evaluate the effectiveness and monitor implementation of a community-informed multi-component intervention (“CombinADO strategy”) addressing individual-, facility-, and community-level factors to improve health outcomes for AYAHIV. Methods This trial will be conducted in 12 clinics in Nampula Province, Northern Mozambique. All clinics will implement an optimized standard of care (control) including (1) billboards/posters and radio shows, (2) healthcare worker (HCW) training, (3) one-stop adolescent and youth-friendly services, (4) information/motivation walls, (5) pill containers, and (6) tools to be used by HCW during clinical visits. The CombinADO strategy (intervention) will be superadded to control conditions at 6 randomly selected clinics. It will include five additional components: (1) peer support, (2) informational/motivational video, (3) support groups for AYAHIV caregivers, (4) AYAHIV support groups, and (5) mental health screening and linkage to adolescent-focused mental health support. The study conditions will be in place for 12 months; all AYAHIV (ages 10–24 years, on ART) seeking care in the participating sites will be exposed to either the control or intervention condition based on the clinic they attend. The primary outcome is VS (viral load < 50 copies/mL) at 12 months among AYAHIV attending participating clinics. Secondary outcomes include ART adherence (self-reported and TDF levels) and retention in care (engagement in the preceding 90 days). Uptake, feasibility, acceptability, and fidelity of the CombinADO strategy during implementation will be measured. Trial outcomes will be assessed in AYAHIV, caregivers, healthcare workers, and key informants. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cRCTs. Discussion The CombinADO study will provide evidence on effectiveness and inform implementation of a novel community-informed multi-component intervention to improve retention, adherence, and VS among AYAHIV. If found effective, results will strengthen the rationale for scale up in SSA. Trial registration ClinicalTrials.gov NCT04930367. Registered on 18 June 2021

2020 ◽  
Author(s):  
Melissa A. Stockton ◽  
Bradley N. Gaynes ◽  
Mina C. Hosseinipour ◽  
Audrey E. Pettifor ◽  
Joanna Maselko ◽  
...  

Abstract As in other sub-Saharan countries, the burden of depression is high among people living with HIV in Malawi. However, the association between depression at ART initiation and two critical outcomes—retention in HIV care and viral suppression—is not well understood. Prior to the launch of an integrated depression treatment program, adult patients were screened for depression at ART initiation at two clinics in Lilongwe, Malawi. We compared retention in HIV care and viral suppression at 6 months between patients with and without depression at ART initiation using tabular comparison and regression models. The prevalence of depression among this population of adults newly initiating ART was 27%. Those with depression had similar HIV care outcomes at 6 months to those without depression. Retention metrics were generally poor for those with and without depression. However, among those completing viral load testing, nearly all achieved viral suppression. Depression at ART initiation was not associated with either retention or viral suppression. Further investigation of the relationship between depression and HIV is needed to understand the ways depression impacts the different aspects of HIV care engagement.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Prudence Mbah ◽  
Michael Iroezindu ◽  
Allahna L. Esber ◽  
Nicole Dear ◽  
Domonique Reed ◽  
...  

Abstract Background Support groups for people living with HIV (PLWH) may improve HIV care adherence and outcomes. We assessed the impact of support group attendance on antiretroviral therapy (ART) adherence and viral suppression in four African countries. Methods The ongoing African Cohort Study (AFRICOS) enrolls participants at 12 clinics in Kenya, Uganda, Tanzania, and Nigeria. Self-reported attendance of any support group meetings, self-reported ART adherence, and HIV RNA are assessed every 6 months. Logistic regression models with generalized estimating equations were used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for support group attendance and other factors potentially associated with ART adherence and viral suppression. Results From January 2013 to December 1, 2019, 1959 ART-experienced PLWH were enrolled and 320 (16.3%) reported any support group attendance prior to enrollment. Complete ART adherence, with no missed doses in the last 30 days, was reported by 87.8% while 92.4% had viral suppression <1000copies/mL across all available visits. There was no association between support group attendance and ART adherence in unadjusted (OR 1.01, 95% CI 0.99–1.03) or adjusted analyses (aOR 1.00, 95% CI 0.98–1.02). Compared to PLWH who did not report support group attendance, those who did had similar odds of viral suppression in unadjusted (OR 0.99, 95% CI 0.978–1.01) and adjusted analyses (aOR 0.99, 95% CI 0.97–1.01). Conclusion Support group attendance was not associated with significantly improved ART adherence or viral suppression, although low support group uptake may have limited our ability to detect a statistically significant impact.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S475-S475
Author(s):  
Doris Pierson ◽  
Vaidehi Mujumdar ◽  
Brittany Briceño ◽  
Elaina Cummer ◽  
Kshipra Hemal ◽  
...  

Abstract Background Trauma—emotional, physical, and psychological—is common and associated with increased risk behaviors, low rates of care engagement and viral suppression, and overall poor health outcomes for people living with HIV (PLWH). In the United States, there are limited data on how trauma affects reproductive health beliefs for PLWH and even less data on HIV providers’ understanding and consideration of these experiences in their approach to patients. Methods Fifteen semi-structured interviews were conducted with PLWH and nine semi-structured interviews were conducted with HIV care and service providers at an academic medical center in the Southeastern United States. Transcripts were analyzed using thematic analysis. Each transcript was coded by two investigators and discussed to ensure consensus. Results Participants’ narratives described diverse traumas, including sexual abuse (n = 6), the loss of a loved one (n = 8), and personal illness (n = 7). Types of trauma shared with providers included physical, sexual, illness, loss, and psychological. For patients, trauma was both a motivation for having children and a reason to stop having children. Providers perceived a variety of effects of trauma on both sexual behaviors and reproductive intentions. Reproductive counseling by HIV care providers (n = 5) focused on maintaining a healthy pregnancy and less on reproductive intentions prior to pregnancy. Reproductive discussions with pregnant female patients typically centered on reducing the risk of transmission in utero (including the importance of medication adherence to maintain viral suppression), what will happen during delivery, and breastfeeding risks. Reproductive discussions with males typically centered on preventing infection or re-infection of the mother. Conclusion PLWH interpret their trauma experiences differently, particularly when considering reproduction. Providers may not incorporate this information in counseling around reproductive health, highlighting the need fora trauma-informed healthcare practice that promotes awareness, education on the effect of past traumas on health, and access to appropriate resources. Disclosures All authors: No reported disclosures.


2021 ◽  
Author(s):  
Sean Arayasirikul ◽  
Caitlin M Turner ◽  
Dillon Trujillo ◽  
Jarett Maycott ◽  
Erin C Wilson

BACKGROUND The HIV epidemic has revealed considerable disparities in health among sexual and gender minorities of color within the Unites States, disproportionately affecting men who have sex with men (MSM) and trans women. Social inequities further disadvantage those with intersectional identities through homophobia, anti-trans discrimination, and racism, shaping not only those at-risk for HIV infection, but also HIV prevention and care outcomes. Digital interventions have great potential to address barriers and improve HIV care among MSM and trans women; however, efficacy of digital HIV care interventions vary and need further examination. OBJECTIVE This study assessed 12-month efficacy of a 6-month digital HIV care navigation intervention among young people living with HIV (YPLWH) in San Francisco We examined dose-response relationships between intervention exposure (e.g. text messaging) and viral suppression and mental health. Health electronic navigation (eNavigation or eNav) is a 6-month, text message-based, digital HIV care navigation intervention, in which YPLWH are connected to their own HIV care navigator through text messaging to improve engagement in HIV primary care. METHODS This study had a single-arm, prospective, pre-post design. Eligibility criteria for the study included: identifying as a man who has sex with men or a trans woman; being between the ages of 18 and 34 years; and being newly diagnosed with HIV or not being engaged/retained in HIV care or having a detectable viral load. We assessed and analyzed sociodemographic, intervention exposure, and HIV care and mental health outcome data for participants who completed the 6-month Health eNav intervention. We assessed all outcomes using generalized estimating equations (GEE) to account for within-subjects correlation, and marginal effects of texting engagement on all outcomes were calculated over the entire 12-month study period. Finally, we specified an interaction between texting engagement and time to evaluate the effects of texting engagement on outcomes. RESULTS Over the entire 12-month study period showed that every one-text increase in engagement was associated with an increased odds of undetectable viral load (adjusted odds ratio, aOR = 1.01, 95% CI = 1.00 – 1.02, p = 0.03). We found that mean negative mental health experiences decreased significantly at 12 months compared to baseline for every one-text increase in engagement (coefficient on interaction term: 0.97, 95%CI = 0.96-0.99, p < 0.01). CONCLUSIONS Digital care navigation interventions like Health eNavigation may be a critical component in the health delivery service system as the digital safety net for those whose social vulnerability is exacerbated in times of crisis, disasters, or global pandemics due to multiple social inequities. We found that increased engagement in a digital HIV care navigation intervention helped to improve viral suppression and mental health – intersecting, co-morbid conditions – 6-months after the intervention concluded. Digital care navigation may be a promising, effective, sustainable, and scalable intervention. INTERNATIONAL REGISTERED REPORT RR2-10.2196/16406


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Kenneth R. Katumba ◽  
Yoko V. Laurence ◽  
Patrick Tenywa ◽  
Joshua Ssebunnya ◽  
Agata Laszewska ◽  
...  

Abstract Background It is rare to find HIV/AIDS care providers in sub-Saharan Africa routinely providing mental health services, yet 8–30% of the people living with HIV have depression. In an ongoing trial to assess integration of collaborative care of depression into routine HIV services in Uganda, we will assess quality of life using the standard EQ-5D-5L, and the capability-based OxCAP-MH which has never been adapted nor used in a low-income setting. We present the results of the translation and validation process for cultural and linguistic appropriateness of the OxCAP-MH tool for people living with HIV/AIDS and depression in Uganda. Methods The translation process used the Concept Elaboration document, the source English version of OxCAP-MH, and the Back-Translation Review template as provided during the user registration process of the OxCAP-MH, and adhered to the Translation and Linguistic Validation process of the OxCAP-MH, which was developed following the international principles of good practice for translation as per the International Society for Pharmacoeconomics and Outcomes Research’s standards. Results The final official Luganda version of the OxCAP-MH was obtained following a systematic iterative process, and is equivalent to the English version in content, but key concepts were translated to ensure cultural acceptability, feasibility and comprehension by Luganda-speaking people. Conclusion The newly developed Luganda version of the OxCAP-MH can be used both as an alternative or as an addition to health-related quality of life patient-reported outcome measures in research about people living with HIV with comorbid depression, as well as more broadly for mental health research.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marwân-al-Qays Bousmah ◽  
Marie Libérée Nishimwe ◽  
Christopher Kuaban ◽  
Sylvie Boyer

Abstract Background To foster access to care and reduce the burden of health expenditures on people living with HIV (PLHIV), several sub-Saharan African countries, including Cameroon, have adopted a policy of removing HIV-related fees, especially for antiretroviral treatment (ART). We investigate the impact of Cameroon’s free antiretroviral treatment (ART) policy, enacted in May 2007, on catastrophic health expenditure (CHE) risk according to socioeconomic status, in PLHIV enrolled in the country’s treatment access program. Methods Based on primary data from two cross-sectional surveys of PLHIV outpatients in 2006–2007 and 2014 (i.e., before and after the policy’s implementation, respectively), we used inverse propensity score weighting to reduce covariate imbalances between participants in both surveys, combined with probit regressions of CHE incidence. The analysis included participants treated with ART in one of the 11 HIV services common to both surveys (n = 1275). Results The free ART policy was associated with a significantly lower risk of CHE only in the poorest PLHIV while no significant effect was found in lower-middle or upper socioeconomic status PLHIV. Unexpectedly, the risk of CHE was higher in those with middle socioeconomic status after the policy’s implementation. Conclusions Our findings suggest that Cameroon’s free ART policy is pro-poor. As it only benefitted PLHIV with the lowest socioeconomic status, increased comprehensive HIV care coverage is needed to substantially reduce the risk of CHE and the associated risk of impoverishment for all PLHIV.


Author(s):  
Dharma N. Bhatta ◽  
Jennifer Hecht ◽  
Shelley N. Facente

Background: Stigma and discrimination are major challenges faced by people living with HIV (PLWH), and stigma continues to be prevalent among PLWH. We conducted a cross-sectional study of 584 men who have sex with men (MSM) living with HIV between July 2018 and December 2020, designed to better understand which demographic and behavioral characteristics of MSM living with HIV in San Francisco, California are associated with experience of stigma, so that programs and initiatives can be tailored appropriately to minimize HIV stigma’s impacts. Methods: This analysis was conducted with data from San Francisco AIDS Foundation (SFAF) encompassing services from multiple different locations in San Francisco. Data about the level of HIV-related stigma experienced were collected through a single question incorporated into programmatic data collection forms at SFAF as part of the client record stored in SFAF’s electronic health record. We performed linear regression to determine the associations between self-reported experiences of HIV stigma and other characteristics among MSM living with HIV. Results: HIV stigma was low overall among MSM living with HIV who are actively engaged in HIV care in San Francisco; however, it was significantly higher for the age groups of 13–29 years (adjusted risk difference (ARD): 0.251, 95% CI: 0.012, 0.489) and 30–49 years (ARD: 0.205, 95% CI: 0.042, 0.367) when compared to the age group of 50 years and older, as well as people who were homeless (ARD: 0.844, 95% CI: 0.120, 1.568), unstably housed (ARD: 0.326, 95% CI: 0.109, 0.543) and/or having mental health concerns (ARD: 0.309, 95% CI: 0.075, 0.544), controlling for race, injection history, and viral load. Conclusions: These findings highlight an opportunity to develop culturally, socially, and racially appropriate interventions to reduce HIV stigma among MSM living with HIV, particularly for younger men and those struggling with housing stability and/or mental health.


2017 ◽  
Vol 31 (1) ◽  
pp. 109-138 ◽  
Author(s):  
Mark J. Siedner

Objective: The number of people living with HIV (PLWH) over 50 years old in sub-Saharan Africa is predicted to triple in the coming decades, to 6-10 million. Yet, there is a paucity of data on the determinants of health and quality of life for older PLWH in the region. Methods: A review was undertaken to describe the impact of HIV infection on aging for PLWH in sub-Saharan Africa. Results: We (a) summarize the pathophysiology and epidemiology of aging with HIV in resource-rich settings, and (b) describe how these relationships might differ in sub-Saharan Africa, (c) propose a conceptual framework to describe determinants of quality of life for older PLWH, and (d) suggest priority research areas needed to ensure long-term gains in quality of life for PLWH in the region. Conclusions: Differences in traditional, lifestyle, and envirnomental risk factors, as well as unique features of HIV epidemiology and care delivery appear to substantially alter the contribution of HIV to aging in sub-Saharan Africa. Meanwhile, unique preferences and conceptualizations of quality of life will require novel measurement and intervention tools. An expanded research and public health infrastructure is needed to ensure that gains made in HIV prevention and treamtent are translated into long-term benefits in this region.


2018 ◽  
Vol 109 (5-6) ◽  
pp. 800-809 ◽  
Author(s):  
Beth Rachlis ◽  
Lucia Light ◽  
Sandra Gardner ◽  
Ann N. Burchell ◽  
Janet Raboud ◽  
...  

2018 ◽  
Vol 62 (2) ◽  
pp. 94-107
Author(s):  
Yung-Chen Jen Chiu ◽  
K. B. Boomer ◽  
Liza M. Conyers

Despite medical advancements that have significantly improved the health outcomes of people living with HIV (PLWH), many do not achieve optimal health outcomes due to psychosocial barriers. This 5-year retrospective longitudinal study draws upon the International Classification of Functioning, Disability, and Health (ICF) framework to conceptualize the relationships between personal and environmental factors and health and retention outcomes among a sample of 704 PLWH in Pennsylvania. A generalized estimated equations (GEE) model was used to model retention in care outcomes (at least one medical visit every 6 months) and a general linear mixed (GLM) model was used to analyze immune system health outcomes (CD4%). This exploratory study reveals that gender, age, race, use of antiretroviral (ARV) medications, use of case management service, mental health diagnosis, and alcohol use were significantly associated with retention in care, whereas race, ethnicity, gender, mental health treatment, use of ARV medications, use of case management services, and retention in care status were significantly associated with the immune system health outcome of CD4%. The results suggest a need for rehabilitation interventions to address key psychosocial issues, as rehabilitation counselors have a unique skill set to address the medical case management needs of individuals with HIV. Implications for rehabilitation counselors and educators are discussed.


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