A randomised trial of "Fresh Start" text messaging to improve return to care in people living with HIV who missed appointments in South Africa.

OBJECTIVE: Treatment interruptions are a barrier to successful antiretroviral therapy (ART). "Fresh start messages", which leverage significant days on the calendar (e.g., new year, public holiday) in order to prompt action, have the potential to encourage people living with HIV to return to care. We evaluated a "fresh start" intervention (text messages) to increase return to care in PLHIV who had missed their last appointment. DESIGN: A three arm 1:1:1 individual randomised controlled trial. METHODS: We randomized adults in Capricorn District who had missed ART appointments by more than 28 days to: a) no text message; b) unframed messages (fresh start not mentioned); or c) framed messages (fresh start mentioned). Randomisation was stratified by treatment interruption duration and across two holidays (Youth Day, Mandela Day). The primary outcome was an ART-related clinic visit at ≤45 days of the first message. RESULTS: 9143 participants were randomised. For Youth Day, 1474 and 1468 were sent unframed and framed messages respectively, with 13.4% sent these messages having an ART visit vs 11.9% not sent a message (aOR 1.2; 95% CI:1.0-1.4, p-value = 0.075). For Mandela Day, 1336 and 1334 were sent unframed and framed messages respectively, with 6.7% sent these messages having an ART-related clinic visit vs 5.4% not sent a message (aOR 1.2; 95% CI: 1.0-1.6; p-value = 0.100). CONCLUSIONS: Low-cost text messages sent around a "fresh start" date may increase the likelihood that patients who miss appointments return to care. This study suggests the potential of text messaging for motivating return to care.

Changes in Adherence and Viral Load Suppression Among People with HIV in Manila: Outcomes of the Philippines Connect for Life Study.

The Philippines HIV epidemic is among the fastest growing globally. Infections among men who have sex with men are rising at an alarming rate, necessitating targeted evidence-based interventions to retain people living with HIV in care, support adherence, and reach viral suppression. We conducted a 48-week prospective cohort study of 462 participants in which we provided a mobile health (mHealth) adherence support intervention using the Connect for Life platform. We observed an improvement in adherence, with the proportion of participants taking more than 95% of their antiretroviral therapy (ART) doses increasing from 78.6% at baseline to 90.3% at 48 weeks. Among treatment experienced participants, adherence improved significantly (McNemar's test = 21.88, P < 0.001). Viral load suppression did not change, with 92.6% suppression at baseline and 92.0% at 48 weeks. Illicit drug use was associated with reduced adherence (aOR = 0.56, 95%CI 0.31-1.00, P = 0.05) and being on second-line therapy was associated with poor viral load suppression (aOR = 0.33, 95%CI 0.14-0.78, P = 0.01). Quality of life improved following ART initiation, from a mean of 84.6 points (of a possible 120) at baseline to 91.01 at 48 weeks. Due to technical issues, fidelity to the intended intervention was low, with 22.1% (102/462) of participants receiving any voice calls and most others receiving a scaled-back SMS intervention. The mHealth intervention did not have any observed effect on adherence or on viral load suppression. While evidence of effectiveness of mHealth adherence interventions is mixed, these platforms should continue to be explored as part of differentiated treatment support services.

Differentiated HIV services for transgender people in four South African districts: population characteristics and HIV care cascade.

INTRODUCTION: Transgender people in South Africa are disproportionately affected by HIV, discrimination and stigma. Access to healthcare and health outcomes are poor. Although integrating gender-affirming healthcare with differentiated HIV prevention, care and treatment services has shown improvement in HIV service uptake and health outcomes among transgender people, evidence is lacking on the implementation of differentiated service delivery models in southern Africa. This article describes a differentiated service delivery model across four South African sites and transgender individuals who access these services. We assess whether hormone therapy (HT) is associated with continued use of pre-exposure prophylaxis (PrEP) and viral load suppression. METHODS: In 2019, differentiated healthcare centres for transgender individuals opened in four South African districts, providing gender-affirming healthcare and HIV services at a primary healthcare level. Routine programme data were collected between October 2019 and June 2021. Descriptive statistics summarized patient characteristics and engagement with HIV prevention and treatment services. We conducted a multivariate logistic regression analysis to determine whether HT was associated with viral load suppression and PrEP continued use. RESULTS: In the review period, we reached 5636 transgender individuals through peer outreach services; 86% (4829/5636) of them accepted an HIV test and 62% (3535/5636) were linked to clinical services. Among these, 89% (3130/3535) were transgender women, 5% (192/3535) were transgender men and 6% (213/3535) were gender non-conforming individuals. Of those who received an HIV test, 14% (687/4829) tested positive and 91% of those initiated antiretroviral treatment. Viral load suppression was 75% in this cohort. PrEP was accepted by 28% (1165/4142) of those who tested negative. Five percent (161/3535) reported ever receiving HT through the public healthcare system. Service users who received HT were three-fold more likely to achieve viral load suppression. We did not find any association between HT and continued use of PrEP. CONCLUSIONS: A differentiated HIV and gender-affirming service delivery model at a primary healthcare level is feasible and can enhance service access in South Africa. HT can improve HIV clinical outcomes for transgender people. As trust is established between the providers and population, uptake of HIV testing and related services may increase further.

Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study.

BACKGROUND: The Philippines HIV epidemic is one of the fastest growing epidemics globally, and infections among men who have sex with men are increasing at an alarming rate. Connect for Life Philippines is a mobile health (mHealth) intervention that supports antiretroviral therapy (ART) adherence in this key population through individualized voice calls and SMS text messages. OBJECTIVE: The objective of this process evaluation is to assess the intervention reach, dose delivered and received, fidelity, and acceptability and to describe contextual factors affecting the implementation of an mHealth adherence support intervention for patients on ART in a clinic in Metro Manila, Philippines. METHODS: A mixed methods process evaluation approach was used in an observational cohort study. Quantitative data sources for the process evaluation were call and SMS text message logs obtained from the mHealth platform and questionnaires collected at 12-, 24-, and 48-week study visits. Qualitative data were collected from process reports and through a series of focus group discussions conducted with a subset of participants during the intervention development phase, after an initial 8-week pilot phase, and at the end of the study. RESULTS: The 462 study participants received 31,095 interactive voice calls and 8234 SMS text messages during the study. Owing to technical issues, intervention fidelity was low, with only 22.1% (102/462) of the participants receiving reminders via voice calls and others (360/462, 77.9%) receiving only SMS text messages during the intervention. After 48 weeks in the study, 63.5% (293/462) of the participants reported that they would be quite likely or very likely to recommend the program to a friend, and 53.8% (249/462) of the participants reported that they benefited quite a bit or very much from the intervention. Participants who were on ART for <6 months at the beginning of the study and those who received the daily or weekly pill reminders were more likely to report that they benefited from the intervention (P=.02 and P=.01, respectively). CONCLUSIONS: The Connect for Life intervention had high participant satisfaction and acceptability, especially among those who received high dose of the intervention. However, poor reliability of local telecommunication networks had a large impact on the intervention's usability, fidelity, and dose received.

Casting a Wide Net: HIV Drug Resistance Monitoring in Pre-Exposure Prophylaxis Seroconverters in the Global Evaluation of Microbicide Sensitivity Project.

BACKGROUND: Evidence of HIV drug resistance (HIVDR) in individuals using oral pre-exposure prophylaxis (PrEP) who acquire HIV is limited to clinical trials and case studies. More data are needed to understand the risk of HIVDR with oral PrEP during PrEP rollout. Mechanisms to collect these data vary, and are dependent on cost, scale of PrEP distribution, and in-country infrastructure for the identification, collection, and testing of samples from PrEP seroconverters. METHODS: The Global Evaluation of Microbicide Sensitivity (GEMS) project, in collaboration with country stakeholders, initiated HIVDR monitoring among new HIV seroconverters with prior PrEP use in Eswatini, Kenya, South Africa, and Zimbabwe. Standalone protocols were developed to assess HIVDR among a national sample of PrEP users. In addition, HIVDR testing was incorporated into existing demonstration projects for key populations. LESSONS LEARNED: Countries are supportive of conducting a time-limited evaluation of HIVDR during the early stages of PrEP rollout. As PrEP rollout expands, the need for long-term HIVDR monitoring with PrEP will need to be balanced with maintaining national HIV drug resistance surveillance for pretreatment and acquired drug resistance. Laboratory capacity is a common obstacle to setting up a monitoring system. CONCLUSIONS: Establishing HIV resistance monitoring within PrEP programs is feasible. Approaches to drug resistance monitoring may evolve as the PrEP programs mature and expand. The methods and implementation support offered by GEMS assisted countries in developing methods to monitor for drug resistance that best fit their PrEP program needs and resources.

Interactive Mobile Phone HIV Adherence Support for Men Who Have Sex With Men in the Philippines Connect for Life Study: Mixed Methods Approach to Intervention Development and Pilot Testing.

BACKGROUND: The HIV epidemic in the Philippines is one of the fastest growing epidemics globally, and infections among men who have sex with men are rising at an alarming rate. The World Health Organization recommends the use of mobile health (mHealth) technologies to engage patients in care and ensure high levels of adherence to antiretroviral therapy (ART). Existing mHealth interventions can be adapted and tailored to the context and population served. OBJECTIVE: This study aims to create a locally tailored intervention using a mobile phone platform to support treatment adherence for HIV patients on ART in the Philippines. METHODS: A mixed methods approach guided by the Behavior Change Wheel framework was used to adapt an existing mHealth adherence support platform for the local setting and target population. A literature review, retrospective clinical record review, and focus group discussions with patients were conducted to understand the drivers of ART adherence and tailor the intervention accordingly. The resulting intervention was pilot-tested for 8 weeks, followed by focus group discussions with patients who received the intervention to assess the acceptability of the design. RESULTS: Key issues contributing to nonadherence included side effects, lack of behavioral skills for pill taking, social support, mental health, and substance use. Patients identified mHealth as an acceptable mode of intervention delivery and wanted mHealth services to be highly personalizable. The study team, clinicians, and software developers integrated these findings into the intervention, which included a menu of services as follows: pill reminders, health tips, adherence feedback, appointment reminders, and symptom reporting. During the pilot phase, technical issues in the interactive voice response system (IVRS) were identified and addressed. Patients who participated in the pilot phase expressed a preference for SMS text messaging over the IVRS. Patients responded positively to the appointment reminders and health tips, whereas patient feedback on daily and weekly pill reminders and adherence feedback was mixed. CONCLUSIONS: The mobile phone-based SMS text messaging and IVRS intervention was acceptable to men who have sex with men in Manila, the Philippines, and qualitative analysis suggested that the intervention helped promote ART adherence and appointment attendance.

Depression, Nutrition, and Adherence to Antiretroviral Therapy in Men Who Have Sex With Men in Manila, Philippines.

Introduction: Depression is the most frequently observed psychiatric disorder among HIV patients. The effect of depression on adherence among men who have sex with men (MSM) HIV patients has not been well studied in the Philippines. Depression is commonly undiagnosed and consequently untreated, which leads to a negative influence on antiretroviral therapy (ART) adherence. Other risk factors such as HIV-related stigma, self-body image satisfaction, and nutritional status are recognized as potential barriers to access HIV prevention and treatment services issues and poor adherence. Methods: Hospital anxiety and depression scale (HADS) was used to screen depressive symptoms during scheduled clinic visits. ART adherence was self-reported using a visual analog scale questionnaire covering the last 30 days. Structured questionnaires were used for measuring risk factors and socio-demographic data. Anthropometry was conducted and body composition was assessed using bioelectrical impedance analysis. Results: One-hundred and ninety-three participants were recruited from the SHIP clinic between 7th March and 30th September 2018, of whom, 42 (21.8%) screened positive for depression (HADS score ≥ 8) and 24 (12.4%) were non-adherent to ART (<95% of medication taken as prescribed). The most common reported reason for non-adherence was simply forgotten (18 out of 42, 42.9%). Increasing depressive symptoms were associated with non-adherence [crude odds ratio (OR) = 1.13; 95% CI: 1.02-1.26]. Social family support (SFS) and body image (BI) scores were also associated with non-adherence, but were not statistically significant in multivariable models. Factors significantly associated with depressive symptoms (but not non-adherence) included the following: using intravenous drugs, being in a relationship, anxiety, self-esteem, and stigma scores. Conclusions: Increased depression symptoms, low social family support, and body image dissatisfaction may be interconnected risk factors for ART non-adherence among Filipino MSM HIV patients. Comprehensive mental health services beyond regular post-HIV testing counseling may increase adherence to ART and improve HIV treatment outcomes. Further prospective studies are needed to address the causal/reverse causal pathway between depression and non-adherence.

Risk factors affecting adherence to antiretroviral therapy among HIV patients in Manila, Philippines: a baseline cross-sectional analysis of the Philippines Connect for Life Study.

Background The Philippines HIV epidemic is one of the fastest growing, globally. Infections among men who have sex with men (MSM) are rising at an alarming rate, necessitating targeted evidence-based interventions to reach epidemic control. Treatment as prevention is a key strategy to end AIDS, making it a priority to explore novel approaches to retain people living with HIV (PLHIV) in care, support adherence, and reach viral suppression. METHODS: This cross-sectional analysis describes HIV-related risk behaviours and adherence to antiretroviral therapy (ART) in a population of HIV-positive patients at a clinic in Metro Manila, Philippines participating in the Philippines Connect for LifeTM cohort study. RESULTS: Among 426 HIV-positive adults taking ART, 79% reported ≥95% adherence over the prior 30 days. Longer time on treatment was associated with reduced adherence to ART (adjusted odds ratio (AOR) = 0.87 per year, P = 0.027). Being in a serodiscordant relationship, in which the subject's primary partner was HIV negative, increased adherence (AOR = 3.19, P = 0.006). Inconsistent condom use (AOR = 0.50, P = 0.103) and injection drug use (AOR = 0.54, P = 0.090) are potentially associated with reduced adherence to ART. Patients used drugs and alcohol at significantly higher rates than the general population.? CONCLUSIONS: The study found that patients in this setting require intervention to address treatment fatigue. Interventions to improve social support of PLHIV, as well as harm-reduction approaches for drug and alcohol use, could improve adherence in this population, strengthening the test-and-treat strategy to control the epidemic.

Adolescent STIs for primary care providers.

PURPOSE OF REVIEW: Sexually transmitted infections (STIs) remain a significant source of morbidity among adolescents, who bear a disproportionate burden of disease. Many infections are asymptomatic, but pose significant risk for long-term sequelae in this at-risk population. RECENT FINDINGS: Recommendations published within the last 5 years from the Centers for Disease Control, United States Preventive Services Task Force, and American Academy of Pediatrics are available to aid providers in appropriate screening, treatment, and prevention of common STIs. However, recent data indicate that many adolescents at risk for STIs are not being appropriately screened. In this review, we summarize screening and treatment recommendations for chlamydia and gonorrhea; prevention and screening recommendations for human papilloma virus (HPV); and appropriate testing for HIV and syphilis. SUMMARY: Primary care providers are in a unique position to address STIs with adolescents. Improved adherence to screening, treatment, and vaccination recommendations by primary care providers is imperative to reduce prevalence, complications, and transmission of STIs in the adolescent population.

Loss to follow-up of stable antiretroviral therapy patients in a decentralized down-referral model of care in Johannesburg, South Africa.

A retrospective record review was conducted for patients down referred to primary health care facilities between 2007 and 2009 to assess the rate and reported reasons for loss to follow-up among stable antiretroviral patients in a down-referral model of care in Johannesburg, South Africa. Missing patients were traced telephonically. Of 3361 patients down referred, 4.11% were lost to follow-up. Most patients who were lost to follow-up were lost at the transfer stage between initiation and maintenance sites. Decentralization and nurse management of ART should be prioritized to increase access to and retention in HIV/AIDS care.