Adaptation and feasibility of WHO PM+ for adolescents living with HIV in KwaZulu-Natal Province, South Africa: an implementation feasibility study protocol

Introduction
Adolescents living with HIV (ALHIV) are an extremely vulnerable population, with the burden of mental health problems carefully documented together with the constraints for receiving timely and adequate management of the problems, especially in rural settings. Problem Management Plus (PM+) is a scalable psychological intervention for individuals impaired by distress in communities exposed to adversity. Initially developed for adult populations, few studies have assessed its potential to address adolescent distress. This study aims to co-adapt PM+ with an adherence component (PM+Adherence) for ALHIV and to evaluate its acceptability and feasibility in rural Kwa-Zulu Natal Province, South Africa.

Methods and analysis
We will use a mixed-methods approach over three phases. The first phase will include a realist synthesis and collection of formative data from up to 60 ALHIV, caregivers and healthcare providers to inform the adaptation of WHO PM+, including the components of an adherence module. During the second phase, we will undertake the cultural adaptation of the PM+Adherence intervention. The third phase will involve a hybrid type 3 implementation strategy among ALHIV aged 16–19 years (n=50) to implement and evaluate the feasibility of the culturally co-adapted PM+Adherence. The feasibility indicators to be evaluated include reach, adoption, attrition, implementation and acceptability of the adapted intervention, which will be assessed qualitatively and quantitatively. In addition, we will assess preliminary effectiveness using an intention-to-treat approach on HIV-related indicators and mental health outcomes at baseline, end intervention, 2-month follow-up during the 6-month implementation.

Discussion
We expect that the PM+Adherence will be acceptable and can feasibly be delivered by lay counsellors in resource-limited rural KwaZulu-Natal.

Ethics and dissemination
Ethical clearance has been obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee, (BREC/00005743/2023). Dissemination plans include presentations at scientific conferences, peer-reviewed publications and community level.

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Luglio 2024

AAP Changes Its Breastfeeding Policy for People With HIV in US

After nearly 40 years, the American Academy of Pediatrics (AAP) is now recommending that pediatricians be ready to support people with HIV who want to breastfeed, provided they meet certain criteria, according to a recent clinical report in Pediatrics. The criteria include starting antiretroviral therapy (ART) before or early in pregnancy, maintaining viral suppression, and being committed to taking ART while breastfeeding.

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Luglio 2024

Impact of HIV coinfection on tuberculosis treatment outcomes in Ethiopia: a systematic review and meta-analysis

Objectives
Despite the implementation of a short-term direct observation treatment programme, HIV coinfection is one of the main determinants of tuberculosis (TB) treatment success. This meta-analysis was conducted to report the impact of HIV on TB treatment outcomes using inconsistent and variable study findings.

Design
Systematic review and meta-analysis was performed.

Data sources
The PubMed/Medline, Web of Science and Google Scholar databases were used to access the articles. The Joanna Briggs Institute (JBI) Meta-Analysis of Statistics Assessment and Review Instrument was used for the critical appraisal.

Eligibility criteria
All observational studies conducted in Ethiopia and reporting TB treatment outcomes in relation to HIV coinfection were included in the final analysis.

Data extraction and synthesis
Two independent reviewers extracted the data using a standardised data extraction format. The JBI critical appraisal tool was used to assess the quality of primary studies. Stata V.14 was used for the data analysis. Cochran’s Q statistic with inverse variance (I2) and funnel plot are used to assess the presence of heterogeneity (I2=94.4%, p

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Luglio 2024

Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study protocol: a prospective observational cohort study of reproductive-aged women living with HIV

Introduction
Over 265 000 women are living with HIV in the USA, but limited research has investigated the physical, mental and behavioural health outcomes among women living with HIV of reproductive age. Health status during the reproductive years before, during and after pregnancy affects pregnancy outcomes and long-term health. Understanding health outcomes among women living with HIV of reproductive age is of substantial public health importance, regardless of whether they experience pregnancy. The Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study is a prospective observational cohort study designed to investigate physical and mental health outcomes of young women living with HIV as they age, including HIV disease course, engagement in care, reproductive health and choices and cardiometabolic health. We describe the HOPE study design, and characteristics of the first 437 participants enrolled as of 1 January 2024.

Methods and analysis
The HOPE study seeks to enrol and follow 1630 women living with HIV of reproductive age, including those with perinatally-acquired HIV, at 12 clinical sites across 9 US states and Puerto Rico. HOPE studies multilevel dynamic determinants influencing physical, mental and social well-being and behaviours of women living with HIV across the reproductive life course (preconception, pregnancy, post partum, not or never-pregnant), informed by the socioecological model. Key research areas include the clinical course of HIV, relationship of HIV and antiretroviral medications to reproductive health, pregnancy outcomes and comorbidities and the influence of racism and social determinants of health. HOPE began enrolling in April 2022.

Ethics and dissemination
The HOPE study received approval from the Harvard Longwood Campus Institutional Review Board, the single institutional review board of record for all HOPE sites. Results will be disseminated through conference presentations, peer-reviewed journals and lay summaries.

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Luglio 2024

Intervention fidelity and factors affecting the process of implementing a mobile phone text messaging intervention among adolescents living with HIV: a convergent mixed-methods study in southern Ethiopia

Objective
To assess the intervention fidelity and explore contextual factors affecting the process of implementing a mobile phone text messaging intervention in improving adherence to and retention in care among adolescents living with HIV, their families and their healthcare providers in southern Ethiopia.

Design
A convergent mixed-methods design guided by the process evaluation theoretical framework and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework was used alongside a randomised controlled trial to examine the fidelity and explore the experiences of participants in the intervention.

Setting
Six hospitals and five health centres provide HIV treatment and care to adolescents in five zones in southern Ethiopia.

Participants
Adolescents (aged 10–19), their families and their healthcare providers.

Intervention
Mobile phone text messages daily for 6 months or standard care (control).

Results
153 participants were enrolled in the process evaluation. Among the 153 enrolled in the intervention arm, 78 (49.02%) were male and 75 (43.8%) were female, respectively. The mean and SD age of the participants is 15 (0.21). The overall experiences of implementing the text messages reminder intervention were described as helpful in terms of treatment support for adherence but had room for improvement. During the study, 30 700 text messages were sent, and fidelity was high, with 99.4% successfully delivered text messages during the intervention. Barriers such as failed text messages delivery, limitations in phone ownership and technical limitations affected fidelity. Technical challenges can hinder maintenance, but a belief in the future of digital communication permeates the experiences of the text message reminders.

Conclusions
Overall fidelity was high, and participants’ overall experiences of mobile phone text messages were expressed as helpful. Contextual factors, such as local telecommunications networks and local electric power, as well as technical and individual factors must be considered when planning future interventions.

Trial registration number
PACTR202107638293593.

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Luglio 2024

Global and regional burden estimation of HIV-associated non-Hodgkins lymphoma: a meta-analysis and modelling analysis protocol

Introduction
HIV infection is one of the complex aetiologies of non-Hodgkin’s lymphoma (NHL). However, the contribution of HIV to burden of NHL across time and region has not yet been comprehensively reported and quantified. Thus, this study aims to evaluate the relative risk of NHL in individuals with HIV infection compared with those without by performing a comprehensive meta-analysis. Additionally, we intend to further estimate quantitatively the degree of HIV contributing to burden of NHL using population attributable fraction (PAF) modelling analysis.

Methods and analysis
This study will screen a mass of records searched from four electronic databases (PubMed, Embase, Cochrane Library and Web of Science). The main outcomes are specific effect values and corresponding 95% CIs for NHL among population with HIV infection compared with those without to quantify the association between HIV infection and NHL. After quality assessment and data extraction, we will undertake a meta-analysis to calculate the pooled risk ratio (RR). Furthermore, PAF calculation based on pooled RR combines with number of age-specific disability-adjusted life year (DALY) and HIV prevalence data (aged ≥15 years old) from 1990 to 2019, at global, regional and country levels. We will calculate the PAF, HIV-associated DALY number and age-standardised rate to quantify the burden of HIV-associated NHL.

Ethics and dissemination
This study is based on published articles; thus, the ethic approval is not essential. In addition, we intend to publish the results on peer-reviewed journals for more discussion. We believe that research on estimating global burden of NHL can provide valuable insights for developing targeted prevention and control strategies, thereby achieving significant benefits.

PROSPERO registration number
CRD 42023404150.

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Giugno 2024

Reducing intersectional stigma among transgender women in Brazil to promote uptake of HIV testing and PrEP: study protocol for a randomised controlled trial of Manas por Manas

Introduction
Globally, transgender (‘trans’) women experience extreme social and economic marginalisation due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are oppressed multiple times. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, as well as race-based stigma to generate a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the ‘most at-risk’ group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups. Through extensive formative work, we developed Manas por Manas, a multilevel intervention using HIV prevention strategies with demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement in the HIV prevention continuum.

Methods and analysis
We are conducting a two-arm randomised wait-list controlled trial of the intervention’s efficacy in São Paulo, Brazil, to improve uptake of HIV testing and PrEP among transgender women (N=400). The primary outcomes are changes in HIV testing (self-testing and clinic based), changes in PrEP uptake and changes in PrEP persistence at baseline and follow-up assessment for 12 months at 3-month intervals.

Ethics and dissemination
This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Comissão Nacional de Ética em Pesquisa (Research Ethics National Commission, CAAE: 25215219.8.0000.5479) in Brazil. Participants provided informed consent before enrolment. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations.

Trial registration number
NCT03081559.

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Giugno 2024

Qualitative evaluation of digital vending machines to improve access to STI and HIV testing in South West England: using a Person-Based Approach

Objectives
To report the development, implementation, acceptability and feasibility of vending machines offering HIV and sexually transmitted infection (STI) testing kits.

Design
A qualitative study using the Person-Based Approach with patient and public involvement workshops and stakeholder involvement and interviews with machine users, sexual health service (SHS) staff, venue staff and local authority sexual health commissioners. Transcripts were analysed thematically.

Setting
Bristol, North Somerset and South Gloucestershire (BNSSG).

Participants
15 machine users, 5 SHS staff, 3 venue staff and 3 local authority commissioners.

Intervention
Four vending machines dispensing free HIV self-testing and STI self-sampling kits in publicly accessible venues across BNSSG were introduced to increase access to testing for groups at higher risk of HIV and STI infection who are less likely to access SHS clinic testing services (young people, people from black communities, and gay, bisexual and other men who have sex with men).

Results
Machine users reported the service was convenient, easy to use and accessible; however, concerns regarding privacy related to machine placement within the venues and issues of maintenance were raised. Promotional material was inclusive and informative; however, awareness of the service through the promotional campaign was limited. Vending machines were acceptable to venue staff once clear processes for their management were agreed with the SHS. SHS staff identified challenges with the implementation of the service related to the limited involvement of the whole SHS team in the planning and development.

Conclusions
The codeveloped vending machine service was acceptable, addressing some barriers to testing. Resources and protected staff time are needed to support greater involvement of the whole SHS team and service providers in venues. Adopting a similarly robust coproduction approach to the implementation of the machines could avoid the challenges reported. The placement of the machines to assure users privacy and repeated, targeted promotion could encourage service use among target groups.

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Giugno 2024

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

Introduction
Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia.

Methods and analysis
This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15–50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel.

Ethics and dissemination
The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

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Giugno 2024

Cohort profile: longitudinal and population comparison of children who are HIV-exposed uninfected and children who are HIV unexposed in Kenya (HOPE study)

Purpose
Globally, the number of children/adolescents exposed to HIV but uninfected (HIV-exposed uninfected, HEU) is growing. The HEU outcomes: population-evaluation and screening strategies study was designed to provide population-level evidence of the impact of HIV and recent antiretroviral therapy regimen exposure on neurodevelopmental, hearing and mental health outcomes from infancy to adolescence.

Participants
The study includes a prospective mother–infant cohort and cross-sectional child/youth–caregiver cohorts conducted in Kenya.
Between 2021 and 2022, the study enrolled 2000 mother–infant pairs (1000 HEU and 1000 HIV-unexposed uninfected (HUU)) for longitudinal follow-up. Infants were eligible if they were aged 4–10 weeks and healthy. Mothers were eligible if their HIV status was known and were ≥18 years. Study visits are 6 monthly until the child reaches age 3 years.
Cross-sectional cohorts spanning ages 3–18 years started enrolment in 2022. Target enrolment is 4400 children/youth (4000 HEU and 400 HUU). Children and youth are eligible if they are HIV negative, maternal HIV status and timing of diagnosis is known, and caregivers are ≥18 years.
Data on infant/child/youth growth, neurodevelopment, mental health, morbidity and hearing are collected at enrolment using standardised tools. Dry blood spots samples are collected for telomere length assessment at baseline and yearly for the longitudinal cohort. Growth z-scores, neurodevelopmental scores, telomere length and prevalence of developmental and hearing problems will be compared between HEU/HUU populations.

Findings to date
Full cohort enrolment for the longitudinal cohort is complete and participants are in follow-up. At 1 year of age, comparing HEU to HUU neurodevelopment using the Malawi developmental assessment tool, we found that HEU infants had higher language scores and comparable scores in fine motor, gross motor and social scores. The cross-sectional cohort has enrolled over 2000 participants and recruitment is ongoing.

Future plans
Longitudinal cohort follow-up and enrolment to the cross-sectional study will be completed in June 2024.

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Giugno 2024