Point-of-care tenofovir (POC TFV) testing could provide a means of antiretroviral therapy (ART) adherence monitoring for people living with HIV (PLWH), allowing for earlier detection of adherence issues and timely interventions. In this qualitative study, we assessed the acceptability of a POC TFV testing intervention among PLWH and healthcare providers. We conducted in-depth interviews with 20 PLWH and eight healthcare providers participating in the STREAM HIV trial in KwaZulu-Natal, South Africa. We conducted thematic analyses of the acceptability, appropriateness, feasibility, and willingness to use the test, as well as participants' preferred form of adherence monitoring and differentiated implementation strategies. Participants found POC TFV testing highly acceptable, appropriate, preferable to self-reporting adherence, and feasible to integrate into care. POC TFV testing was well-liked and perceived to have several positive effects. Participants' desire to impress and build trust with their provider motivated them to take their ART daily to achieve a positive adherence test result at each clinic visit. Nearly all PLWH preferred POC TFV testing over self-reporting their adherence, and all healthcare providers were willing to use the test in routine care. Overall, POC TFV testing may be an acceptable and beneficial tool for improving HIV care and strengthening client-provider relations.
BackgroundFor people with HIV (PWH), long-acting antiretroviral therapies (LA-ART) are promising treatment alternatives to daily oral regimens, with potential to improve adherence and achieve viral suppression. Understanding patient preferences is crucial for successful and efficient implementation and scaling of LA-ART in resource-limited settings such as Kenya. We conducted a discrete choice experiment (DCE) to elicit preferences for LA-ART attributes among PWH in Kenya.MethodsWe recruited 700 PWH taking daily oral ART from Kenyatta National Hospital and two Sex Workers Outreach Program clinics in Nairobi. In 17 choice scenarios, participants chose between their current daily oral regimen and two hypothetical LA-ART alternatives defined by seven attributes: delivery mode (long-acting oral, subcutaneous or intramuscular injection, implant), administration location (clinic, chemist, home), frequency (weekly, every 1, 2, 3, 6, or 12 months), delivery-site pain (none, mild, moderate), pre-treatment viral suppression (required, not required), pre-treatment negative reaction testing (required, not required), and late-dose leeway (short, long). We used conditional logistic regressions with interactions between mode and pain to determine the relative importance in participants' choices across attributes.ResultsParticipants had a median age of 36 years (interquartile range [IQR]: 28-46); 64% were female, 83% were virally suppressed, 51% were from key populations (e.g., sex workers or men who have sex with men), and median time on ART was 9 years (IQR: 5-15). Participants generally preferred the hypothetical LA-ART options over their current daily oral ART, and the interaction of delivery mode and pain was the most important attribute combination. Oral LA-ART was the most preferred mode; 1-year implants with mild pain was the next preferred option. Participants favored administration at clinics to chemists or home and preferred less frequent dosing.ConclusionsLA-ART would be highly acceptable in Kenya, with oral LA-ART and administration at clinics as the preferred formulation and location. Our findings provide valuable evidence to guide the development of novel LA-ART products. Future research should evaluate preference heterogeneity and investigate ways to effectively scale LA-ART in Kenya and similar settings, while taking into account patient preferences.Clinical trial numberNot applicable.
Objective This trial examined the noninferiority of family-based behavioral pediatric weight management treatment (FBT) delivered by peers relative to professionals. Methods Children (n = 127) aged 7 to 11 years with BMI > 85th percentile for age and sex and at least one parent with BMI > 25 kg/m(2) were randomly assigned to receive FBT delivered by parents who had previously received FBT from professionals. Child and parent anthropometrics and child quality of life were measured prior to FBT, at treatment end, and at 12-month follow-up. Treatment fidelity, adherence, and costs were examined by delivery mode. Results Peer FBT delivery was noninferior to professional FBT delivery (margin of 0.072 in child BMI z score change) at treatment end and at 12-month follow-up; however, superiority testing suggested that professional FBT delivery resulted in better child BMI z score change. No differential changes were observed in child quality of life or parental BMI by FBT delivery mode. Peer-delivered FBT was well received, with peers providing personal examples of behavior change success but less skills-focused content. Peer FBT delivery was about one-quarter the cost of professional FBT delivery. Conclusions This study informs new strategies for sustaining the delivery of pediatric obesity interventions by involving trained parents.
Men who have sex with men (MSM) bear a disproportionate burden of HIV and mental health problems in China, hindering HIV-related care engagement and medication adherence. We developed a culturally-tailored dialectical behavior therapy (DBT)-informed mHealth intervention composed of individual skills training through a mobile app, online skills group, and on-demand skills coaching. The primary objective of this feasibility study was to assess the intervention acceptability, feasibility, and app usability. The secondary aim is to explore preliminary intervention effects. Participants were recruited in collaboration with Shanghai China Sex Worker Men Who Have Sex with Men Center (SCMC), a community-based organization that provides HIV-related services in Shanghai, China. Eligible participants were randomly assigned to a 4-week mHealth intervention or control arm (treatment as usual). The intervention included individual skills learning using an app, online skills group facilitated by trained SCMC staff, and on-demand skills coaching by trained SCMC staff. Both groups completed weekly surveys for 4 weeks. Quantitative data were analyzed using linear mixed-effects models to evaluate the intervention’s impact on primary outcomes (depression, anxiety, quality of life, medication adherence) and intermediate outcomes (emotion regulation difficulties, HIV-related stigma, and coping self-efficacy). Quantitative and qualitative data on intervention feasibility, acceptability, and app usability were analyzed using content analysis and supplemented with quantitative data summarized with descriptive statistics. Of the 64 people who completed the screening survey, 31 enrolled and completed the study without dropping out. The intervention (n = 16) and control arm (n = 14) did not differ in demographic characteristics, primary outcomes, or intermediate outcomes at baseline. Most participants were 23–30 years old, college-educated, employed, and single. Overall, the intervention was perceived to be highly feasible and acceptable, with above-average app usability. Compared to the control group, time was significantly associated with a greater decrease in the following outcomes in the intervention group: depression (β = − 0.73, 95
BACKGROUND:Long-acting antiretroviral therapy (LA-ART) is an emerging alternative to daily oral ART pills that may improve HIV treatment adherence. We studied preference heterogeneity for LA-ART among people with HIV (PWH) in western Washington State and Atlanta, Georgia to determine how preference heterogeneity was related to individual characteristics. METHODS:We recruited 699 PWH to complete a survey including 17 choice-tasks, each of which included two hypothetical LA-ART alternatives and current daily oral therapy. Each hypothetical alternative was defined by mode (long-acting [LA] oral pills, subcutaneous injections, intramuscular injections, and implants), frequency, treatment location (home, clinic, or pharmacy), injection pain, pre-treatment time undetectable, pre-treatment reaction testing, and late-dose leeway. We fitted a latent class model to the data and investigated associations between class membership and individual characteristics. RESULTS:Our sample had three classes which were defined by their treatment preferences. Two classes preferred LA-ART over current treatment: the LA-Implant class (29%) and the LA-Oral-or-Injection class (35%). In contrast, the Daily-or-LA-Oral class (36%) preferred current treatment or LA oral pills taken at home. Compared to the third class, participants from the other two were younger, more educated, less adherent to current ART, and less averse to injections. Further, LA-Implant participants were less likely to be virally suppressed and had easier clinic access. LA-Oral-or-Injection participants had a higher prevalence of psychotic disorders. CONCLUSION:These results provide a deeper understanding of the preference landscape for LA-ART and can aid in the development of interventions better aligned with individual preferences.
Sexual minority men (SMM) in China are disproportionately affected by the HIV epidemic, yet utilization of HIV prevention services, such as pre-exposure prophylaxis (PrEP), remains low. This systematic review summarizes the barriers and facilitators to the PrEP care continuum among Chinese SMM using thematic analysis. Following PRISMA guidelines, a comprehensive literature search was conducted in English and Chinese databases, including PubMed, EMBASE, Web of Science, PsycINFO, CINAHL, CNKI and WanFang. From 820 records, 50 studies met inclusion criteria, revealing five key themes: (1) sexual behaviors and perceived HIV risk; (2) PrEP-related stigma and homophobia; (3) history of HIV and other STI care engagement; (4) perceptions of PrEP efficacy, side-effects and adherence, and (5) structural and access barriers, including cost, health insurance and residential status. Improving PrEP uptake among Chinese SMM requires addressing sexual risk behaviors, societal stigma and structural barriers. Comprehensive education around PrEP, stigma reduction and financial support are crucial. Targeted public health initiatives and policy changes are necessary to enhance PrEP awareness, accessibility and adherence among Chinese SMM. Additionally, integrating PrEP education into existing HIV/STI care frameworks, and fostering supportive environments within healthcare settings can further mitigate barriers. There is a need to explore and promote alternative PrEP modalities, including on-demand (event-driven) PrEP and long-acting injectable PrEP, to better meet the diverse needs of Chinese SMM. Collaboration between government, healthcare providers and community organizations is essential to develop and implement effective strategies for increasing PrEP uptake and ensuring sustained HIV prevention efforts among Chinese SMM.
Antiretroviral therapy (ART) use and HIV suppression among people living with HIV (PLHIV) are critical for HIV control and prevention. Extreme restrictions on movement early during the COVID-19 pandemic in Uganda may have impeded the ability to initiate and sustain access to and use of ART. From our stepped-wedge cluster-randomized trial of an integrated PrEP and ART intervention for HIV-serodifferent couples at 12 ART clinics in Uganda, we identified participants who enrolled and had a 6-month post-ART initiation viral load measured before the beginning of the first COVID-19 lockdown (Period 1), participants whose enrollment and 6-month viral load measurement straddled pre-COVID and COVID lockdown times (Period 2), and participants whose enrollment and 6-month viral load were quantified entirely during COVID-19 (Period 3). ART and viral load data were abstracted from standard-of-care HIV clinic records. We used adjusted generalized estimating equation models to compare viral suppression between the different periods. We enrolled 1,381 PLHIV, including 896 (64.9%) in Period 1, 260 (18.8%) in Period 2, and 225 (16.3%) in Period 3. Almost all (1371, 99.3%) initiated ART within 90 days of enrollment and 59.2% had baseline CD4 > 350 cells/mm 3 . Among those enrolled, 88.8% of participants in Period 1 were virally suppressed (< 1000 copies/mL) within six months of ART initiation, 80.5% in Period 2, and 88.2% in Period 3. All pairwise comparisons demonstrated statistically similar levels of viral suppression. Despite COVID-19 lockdown measures, PLHIV in serodifferent partnerships successfully initiated ART and attained and maintained viral suppression.
Long-acting antiretroviral therapy (LA-ART) could increase viral suppression among people living with HIV (PLWH) by promoting ART uptake and adherence. We adapted and pilot-tested a discrete-choice experiment (DCE) and an associated survey that were previously implemented in the United States, based on key informant interviews with Kenyan HIV experts and research team discussion about changes needed for the Kenyan context. We conducted five waves of pilot-testing, each with 9-11 PLWH receiving care at the Kenyatta National Hospital Comprehensive Care Clinic, iteratively updating the DCE (which elicited participant preferences) and the survey (which collected data on participant characteristics) as required. We enrolled 50 participants (median age 36, 56% male) between May and November 2022. Overall understanding of the DCE instructions and choice tasks was good, with the majority needing no assistance and most others needing minimal assistance. Most edits made during pilot testing were to questions in the survey rather than the DCE text or design. Preliminary results assessed using conditional logistic regression were similar to results of the US DCE: Across all participants, LA-ART alternatives were preferred over current daily oral ART, with the strongest preference for a long-acting oral pill. Full implementation with 700 participants is underway.
Behavioral interventions are widely used in clinical trials supported by the National Institutes of Health (NIH). When behavioral interventions involve group-formatted components and/or shared interventionists, they require special design and analytic methods not needed in trials that do not involve these features. The NIH Office of Disease Prevention (ODP) and the NIH Office of Behavioral and Social Sciences Research (OBSSR) offer resources to make it easier for investigators to use appropriate methods to evaluate these interventions. This commentary draws attention to these issues and highlights the ODP and OBSSR resources available to investigators. We urge investigators to take advantage of these resources to learn about and adopt appropriate sample size and analytic methods for trials to evaluate behavioral interventions so that their results will be reliable and reproducible. That is the best way to advance the science of behavioral interventions to improve health.
Pre-exposure prophylaxis (PrEP), including daily oral, on-demand, and long-acting injectable (LAI), is a promising HIV prevention intervention for men who have sex with men (MSM). We conducted a systematic review on engagement with the PrEP continuum among MSM in China. A total of 756 studies were initially identified and 36 studies were included (N = 26,021). In the 20 studies (N = 13,886) examining PrEP awareness, 32.4
Integrating Pre-Exposure Prophylaxis (PrEP) delivery into Antiretroviral Therapy (ART) programs bridges the Human Immunodeficiency Virus (HIV) prevention gap for HIV-serodifferent couples prior to the partner living with HIV achieving viral suppression. Behavioral modeling is one mechanism that could explain health-related behavior among couples, including those using antiretroviral medications, but few tools exist to measure the extent to which behavior is modeled. Using a longitudinal observational design nested within a cluster randomized trial, this study examined the factor structure and assessed the internal consistency of a novel 24-item, four-point Likert-type scale to measure behavioral modeling and the association of behavioral modeling with medication-taking behaviors among heterosexual, cis-gender HIV-serodifferent couples. In 149 couples enrolled for research, a five-factor model provided the best statistical and conceptual fit, including attention to partner behavior, collective action, role modeling, motivation, and relationship quality. Behavioral modeling was associated with medication-taking behaviors among members of serodifferent couples. Partner modeling of ART/PrEP taking could be an important target for assessment and intervention in HIV prevention programs for HIV serodifferent couples.
Men who have sex with men (MSM) bear a disproportionate burden of HIV in China and are particularly vulnerable to mental health challenges. This study is phase one of a multi-phase project that aimed to identify unmet needs of MSM living with HIV to inform the development of a multi-level intervention. We interviewed 24 stakeholders through videoconferencing, including 15 MSM living with HIV, five staff from a community-based organization serving gender and sexual minority individuals, and four staff from the Centers for Disease Control and Prevention in Shanghai, China. We conducted content analysis using inductive and deductive coding and identified the following themes: 1) Navigating Turbulent Waters: multi-level stress currents; 2) Mapping Anchors: multifaceted support network; 3) Staying Afloat: Daily strategies and functioning; and 4) Charting New Courses: paths for intervention. Examining the stress and coping process among MSM living with HIV from a socio-ecological lens is especially important in the collective cultural context. The interactive nature of the stress from multiple socio-ecological levels, lack of individual coping skills, and scarcity of psychosocial services highlighted the importance of community-based, multi-level interventions to meet the needs of MSM living with HIV in China.
The COVID-19 pandemic and social distancing measures elevated stress levels globally, exacerbating mental health challenges for people with HIV (PWH). We examined the effect of COVID-19-related stress on mental health among PWH in western Washington, exploring whether social support and coping self-efficacy were protective. Data on COVID-19-related stress, mental health, social support, and coping self-efficacy were collected using online surveys during the pandemic. Pre-COVID-19 mental health data were available for a subset of participants and were linked with the survey data. In the total sample (N = 373), COVID-19-stress was associated with elevated depression (PHQ-8, β = 0.21, 95%CI [0.10, 0.32]) and anxiety (GAD-7, β = 0.28, 95%CI [0.17, 0.39]). Among the subset of respondents with pre-pandemic mental health data (N = 103), COVID-19-related stress was associated with elevated PHQ-8 scores (β = 0.35, 95%CI [0.15, 0.56]) and GAD-7 scores (β = 0.35, 95%CI [0.16, 0.54]), adjusted for baseline mental health and other confounders. Coping self-efficacy was negatively associated with GAD-7 scores (β = -0.01, 95%CI [-0.01, 0.00]), while social support was negatively associated with PHQ-8 scores (β = -0.06, 95%CI [-0.12, -0.01]). Viral suppression before and during the pandemic did not differ among participants with available data. While COVID-19-related stress predicted elevated depression and anxiety symptoms among PWH, social support and coping self-efficacy were protective.
Pandemic-related stressors may disproportionately affect the mental health of people with HIV (PWH). Stratified, purposive sampling was used to recruit 24 PWH who participated in a quantitative survey on COVID-19 experiences for in-depth interviews (IDIs). IDIs were conducted by Zoom, audio recorded and transcribed. Thematic analysis was used to develop an adapted stress-coping model. Participants experienced acute stress following exposure events and symptoms compatible with COVID-19. Social isolation and job loss were longer-term stressors. While adaptive coping strategies helped promote mental health, participants who experienced multiple stressors simultaneously often felt overwhelmed and engaged in maladaptive coping behaviors. Healthcare providers were important sources of social support and provided continuity in care and referrals to mental health and social services. Understanding how PWH experienced stressors and coped during the COVID-19 pandemic can help healthcare providers connect with patients during future public health emergencies, address mental health needs and support adaptive coping strategies.
Background:The COVID-19 pandemic and related social distancing greatly impacted quality of life, in part, by disrupting access to social support. We examined the relationship between social support and quality of life among people living with HIV (PWH) who participated in a cross-sectional survey during the COVID-19 pandemic, evaluating differences in this relationship by age and gender. Materials and Methods:Between August 2020 and March 2021, 397 PWH completed an online Research Electronic Data Capture survey. Social support was assessed using the Multidimensional Scale of Perceived Social Support, and health-related quality of life (HRQoL) was assessed using the EuroQol EQ-5D-3L. Linear regression was used to examine the relationship between social support and quality of life, and interaction terms were used to assess effect modification by age and gender. Results:Higher levels of social support were associated with higher self-rated quality of life (adjusted β = 1.05, 95% confidence interval [95% CI]: 0.002, 2.10). This association was moderated by gender, with males having higher HRQoL (adjusted β = 24.5, 95% CI 10.5, 38.6) and a lower slope for the relationship between social support and HRQoL (adjusted β = -0.28, 95% CI -0.50, -0.06) than females. Age did not moderate the relationship between social support and quality of life, but higher age was associated with lower quality of life (adjusted β = -0.18, 95% CI -0.31, -0.05). Conclusion:Higher levels of social support were associated with better quality of life for PWH during the COVID-19 pandemic, especially for women. Our findings suggest that women may be more sensitive to large-scale interruptions in their social support networks than men.
Background In 2020, 14% of diagnosed persons living with HIV (PLWH) in Kenya were not taking antiretroviral therapy (ART), and 19% of those on ART had unsuppressed viral loads. Long-acting antiretroviral therapy (LA-ART) may increase viral suppression by promoting ART uptake and adherence. We conducted key informant (KI) interviews with HIV experts in Kenya to identify product and delivery attributes related to the acceptability and feasibility of providing LA-ART to PLWH in Kenya.Methods Interviews were conducted via Zoom on potential LA-ART options including intra-muscular (IM) injections, subcutaneous (SC) injections, implants, and LA oral pills. KI were asked to discuss the products they were most and least excited about, as well as barriers and facilitators to LA-ART roll-out. In addition, they were asked about potential delivery locations for LA-ART products such as homes, pharmacies, and clinics. Interviews were recorded and transcribed, and data were analyzed using a combination of inductive and deductive coding.Results Twelve KI (5 women, 7 men) participated between December 2021 and February 2022. Overall, participants reported that LA-ART would be acceptable and preferable to PLWH because of fatigue with daily oral pills. They viewed IM injections and LA oral pills as the most exciting options to ease pill burden and improve adherence. KI felt that populations who could benefit most were adolescents in boarding schools and stigmatized populations such as sex workers. SC injections and implants were less favored, as they would require new training initiatives for patients or healthcare workers on administration. In addition, SC injections would require refrigeration and needle disposal after use. Some KI thought patients, especially men, might worry that IM injections and implants would impact fertility, given their role in family planning. Pharmacies were perceived by most KI as suboptimal delivery locations; however, given ongoing work in Kenya to include pharmacies in antiretroviral delivery, they recommended asking patients their views.Conclusion There is interest and support for LA-ART in Kenya, especially IM injections and LA oral pills. Identifying patient preferences for modes and delivery locations and addressing misconceptions about specific products as they become available will be important before wide-scale implementation.
Background HIV and gender-based violence (GBV) intersect to threaten population health. The Uganda Ministry of Health recommends routine GBV screening alongside HIV care but evidence detailing its implementation in HIV care settings is limited. We evaluated screening practices in public HIV clinics to generate evidence supporting GBV screening optimization. Methods To evaluate GBV screening implementation in antiretroviral therapy (ART) clinics, we extracted client data from GBV registers at 12 public ART clinics in Uganda (January 2019-December 2021). We concurrently evaluated perceptions of GBV screening/referral practices by conducting in-depth qualitative interviews with providers (N = 30) and referral partners (N = 10). We contextualized quantitative findings with interview data which were analyzed using a thematic analysis approach. Results During the evaluation period, >90% of providers in participating health facilities implemented GBV screening. Among 107,767 clients served in public ART clinics, providers identified 9,290 (8.6%) clients who experienced past-year physical, sexual and/or emotional GBV of whom 86% received counseling and 19% were referred to support services—most commonly to legal services. Key factors influencing GBV screening implementation included awareness of screening guidelines; client volume; and client’s level of engagement in HIV care. Providers and referral partners identified important benefits to clients (e.g., pursuit of justice and removal from violent environments) when referrals were successful. Key factors influencing referrals included financial constraints that limited referral partners’ ability to provide services at no cost to clients and socio-cultural norms that inhibited client willingness to pursue support services. Conclusions GBV screening implementation in ART clinics supports identification and referral of clients exposed to violence. The effectiveness of GBV screening may be limited by socio-cultural factors that inhibit client capacity to pursue referrals and fragmented and resource-constrained referral networks. Providers and referral partners identified allocating funds to support referrals and collaborative networking meetings as important opportunities for strengthening GBV referrals.