Experiences of oral pre-exposure prophylaxis use among heterosexual men accessing sexual and reproductive health services in South Africa: a qualitative study.

INTRODUCTION: South African men face a substantial burden of HIV and are less likely to test for HIV and initiate antiretroviral therapy if tested positive and more likely to die from AIDS-related causes than women. In addition to condoms and circumcision, guidelines provide for the use of daily oral pre-exposure prophylaxis (PrEP) as an HIV prevention intervention for any men who recognize their need and request PrEP. However, heterosexual men have not been a focus of PrEP programmes, and since its introduction, there is limited literature on PrEP use among men in South Africa. This study explores the experiences, motivators and barriers to oral PrEP use among heterosexual men accessing primary healthcare services in South Africa. METHODS: This study forms part of a mixed-methods implementation science study aimed at generating evidence for oral PrEP introduction and conducted in primary healthcare clinics in South Africa since 2018. Men aged ≥15 years who initiated oral PrEP and enrolled in a parent cohort study were purposefully invited to participate in an in-depth interview (IDI). Between March 2020 and May 2022, 30 men participated in IDIs exploring their motivators for PrEP use, and experiences with accessing health services. Interviews were audio recorded, transcribed and analysed thematically. RESULTS: The final analysis included 28 heterosexual men (18-56 years old). Motivations to initiate PrEP included fear of acquiring HIV, self-perceived vulnerability to HIV and mistrust in relationships; health systems factors which motivated PrEP use included the influence of healthcare providers, educational materials and mobile services. Perceived reduction in HIV vulnerability and changing proximity to partners were reasons for PrEP discontinuation. Side effects, daily-pill burden and stigma were noted as challenges to PrEP use. Health system barriers to PrEP use included limited PrEP availability, school and work demands, and inconsistent mobile clinic schedules. CONCLUSIONS: Our study reports on the experiences of heterosexual men accessing oral PrEP in real-world settings and contributes to the limited literature among this population. We highlight multiple levels which could be strengthened to improve men's PrEP use, including individual support, education among partners and communities, and addressing health system barriers to access.

Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged ≥6 to <12 years, using matching placebo tablets: A randomized study.

BACKGROUND: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed the swallowability and acceptability for long-term use of scored placebo tablets matching the D/C/F/TAF FDC tablets in children living with HIV-1. METHODS: This study (NCT04006704) was a Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence crossover study in children living with HIV-1, aged ≥6 to <12 years and weighing ≥25 to <40 kg, on a stable ARV regimen for ≥3 months. Participants were asked to swallow whole (size, 21 × 11 × 7 mm) and split matching placebo D/C/F/TAF tablets. Swallowability of the matching placebo D/C/F/TAF tablets (primary endpoint) was assessed by observers. Acceptability of taking matching placebo D/C/F/TAF tablets and current ARVs was evaluated by participants using a 3-point questionnaire. Participants rated the acceptability for long-term daily use of the placebo D/C/F/TAF tablets, and observers assessed how easily caregivers could split a scored tablet by hand, using 3-point questionnaires. RESULTS: Among the 24 participants who enrolled and completed the study, 95.8% (23/24) were able to swallow the whole and split matching placebo D/C/F/TAF tablets after 1 or 2 attempts. Most participants (>70%) rated the acceptability of tablets for long-term daily use as acceptable or good to take. Breaking the tablets was considered easy or OK by 79.2% (19/24) of caregivers. CONCLUSION: Scored D/C/F/TAF FDC tablets are swallowable - with whole favoured over split - and considered at least acceptable for long-term daily intake in children living with HIV-1 aged ≥6 to <12 years. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04006704.

Avoiding Shots in the Dark: Learning from the Past To Inform the Implementation of Long-Acting Injectable Pre-Exposure Prophylaxis for Black American Cisgender Women.

The FDA's approval of long-acting injectable cabotegravir pre-exposure prophylaxis (LAI PrEP) as an alternative to daily oral PrEP represents a crucial development in HIV prevention, particularly for American Black cisgender women who face high HIV-1 risks. Yet, uptake may be hindered by racial and gender inequities. Addressing these requires learning from the roll-out of oral PrEP, creating culturally tailored PrEP campaigns, and enhancing provider training to meet Black women's needs. Tools for discussing PrEP within personal relationships and product preference research tailored to Black women's needs are essential for effective LAI PrEP delivery. Deliberative implementation of LAI PrEP must employ strategies that are community-sensitive, -responsive, and -inclusive. It should prioritize the incorporation of Black women's voices in decision-making and should promote community-led strategies. By addressing historical injustices and fostering trust, healthcare systems can enhance LAI PrEP uptake by Black women. Emphasizing a community-centered approach that ensures health equity and acknowledges the crucial role that social media and Black-led organizations play in promoting PrEP awareness and adoption within Black communities is necessary for successful implementation.

Negative impact of a health insurer-mandated de-simplification from a single-tablet regimen to a two-tablet regimen.

OBJECTIVES: Antiretroviral therapy (ART) accounts for a considerable proportion of HIV care expenses. In June 2021, a Dutch healthcare insurer implemented a mandatory policy to de-simplify branded RPV/TDF/FTC (Eviplera) into a two-tablet regimen containing rilpivirine (Edurant) and generic TDF/FTC as part of cost-saving measures. The objectives of this study were to evaluate the acceptance of this policy, the trends in ART dispensation, and cost developments. DESIGN: A retrospective database study. METHODS: In this study, medication dispensation data were obtained from the Dutch Foundation for Pharmaceutical Statistics (SFK). This database covers 98% of all medication dispensations from Dutch pharmacies including people with HIV who receive ART. We received pseudonymized data exclusively from individuals insured by the insurer for the years 2020-2022. Costs were calculated using Dutch drug prices for each year. RESULTS: In June 2021, 128 people with HIV were on branded RPV/TDF/FTC. Following the policy implementation, 59 (46%) had switched to RPV + generic TDF/FTC, but after 1.5 years, only 17 of 128 individuals (13%) used the proposed two-tablet regimen. The other 111/128 used RPV/TDF/FTC with prescriptions for 'medical necessity' ( n  = 29), switched to RPV/TAF/FTC ( n  = 51), or other ART ( n  = 31). Despite expectations of cost-savings, costs increased from €72 988 in May 2021 to €75 649 in May 2022. CONCLUSION: A mandatory switch from an STR to a TTR in people with HIV proved unsuccessful, marked by low acceptance, and increased costs after 1 year. This underscores the necessity of incorporating patient and prescriber involvement in changing medication policies.

A behavioral economics approach to enhancing HIV preexposure and postexposure prophylaxis implementation.

PURPOSE OF REVIEW: The 'PrEP cliff' phenomenon poses a critical challenge in global HIV PrEP implementation, marked by significant dropouts across the entire PrEP care continuum. This article reviews new strategies to address 'PrEP cliff'. RECENT FINDINGS: Canadian clinicians have developed a service delivery model that offers presumptive PEP to patients in need and transits eligible PEP users to PrEP. Early findings are promising. This service model not only establishes a safety net for those who were not protected by PrEP, but it also leverages the immediate salience and perceived benefits of PEP as a natural nudge towards PrEP use. Aligning with Behavioral Economics, specifically the Salience Theory, this strategy holds potential in tackling PrEP implementation challenges. SUMMARY: A natural pathway between PEP and PrEP has been widely observed. The Canadian service model exemplifies an innovative strategy that leverages this organic pathway and enhances the utility of both PEP and PrEP services. We offer theoretical insights into the reasons behind these PEP-PrEP transitions and evolve the Canadian model into a cohesive framework for implementation.

Social, Structural, Behavioral, and Clinical Barriers Influencing Pre-exposure Prophylaxis (PrEP) Use Among Young Black Men Who Have Sex with Men in the South: A Qualitative Update to a 2016 Study.

Antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV. Despite its promise, PrEP use is low, especially among young Black men who have sex with men (YBMSM). The prevalence of HIV in Mississippi (MS) is among the highest in the United States, with the bulk of new infections occurring amongst YBMSM living in Jackson, MS. We recruited 20 PrEP-eligible YBMSM and 10 clinic staff from MS health clinics between October 2021 and April 2022. Data were collected remotely using in-depth interviews and a brief survey, which lasted approximately 45-60 min. Interview content included PrEP knowledge/experiences, HIV risk perception, and PrEP use barriers and facilitators. Qualitative data were coded then organized using NVivo. Using thematic analysis methodology, data were assessed for current barriers to PrEP use. An array of barriers were identified by participants. Barriers included structural factors (cost of PrEP, lack of discreet clinics, time commitment, competing interests); social factors (unaware of HIV risk, stigma and homophobia, fear that partners would find out about PrEP use, not knowing anyone on PrEP); behavioral factors (sexual risk factors, denial, less priority for prevention vs treatment); and clinical factors (misunderstood side effects, fear PrEP won't work). Significant barriers to PrEP use among YBMSM stem from structural, social, behavioral, and clinical factors. These results will inform intervention efforts tailored to mitigate barriers and improve PrEP uptake among YBMSM in the southern United States.

An Assessment of HIV Risk, Perceptions of Risk, and Potential Adherence to Preexposure Prophylaxis Among HIV-Negative People With Injection Drug Use Who Access Mobile Outreach Services.

OBJECTIVE: The purpose of this study was to assess HIV risk, perceptions of risk, and potential adherence to preexposure prophylaxis (PrEP) for the prevention of HIV infection among people who inject drugs (PWID), who self-report HIV negative status and access mobile outreach intravenous drug use (IVDU) services. METHODS/SAMPLE: Participants (N = 93) were non-Hispanic White (59.1%) and Hispanic (36.6%), between the ages of 18 and 63 years, primarily male (58.1%), who reported a length of IVDU between 1 and >20 years and accessed mobile outreach IVDU services in a metropolitan area of the Southwestern United States; all self-reported HIV-negative status. Self-report questionnaires completed via iPad included HIV risk behavior, perceived risk of HIV, and beliefs about medicines. RESULTS: PWID perceived themselves at a low risk for HIV with minimal concerns about contracting HIV. High levels of comorbidities (schizophrenia, anxiety, depression, hepatitis, diabetes, and hypertension), substance use, and limited HIV protective behavior and social support existed; women reported significantly more risk behaviors and comorbidities. Positive attitudes toward and interest in use of medication for HIV prevention were present, however, with concurrent concerns regarding long-term medication use and the potential to forget medications. CONCLUSIONS: PrEP adherence for PWID presents challenges for clinicians. Addressing perceptions of PrEP, perceived and actual risk for contracting HIV, potential barriers to PrEP adherence, social support, and treatment of comorbidities in primary care and IVDU outreach services potentially enhances PrEP maintenance among PWID, notably women.

"If I don't take my treatment, I will die and who will take care of my child?": An investigation into an inclusive community-led approach to addressing the barriers to HIV treatment adherence by postpartum women living with HIV.

INTRODUCTION: Initiatives to support adherence to HIV treatment in South Africa are often centred on service delivery thereby avoiding key challenges to adherence: stigma and poverty. In contrast, this study aims to demonstrate the strength of an inclusive research and programme approach to improving the lives of people living with HIV and simultaneously ARV adherence. METHODS: Participatory Action Research combined with a visual participatory method (Photovoice) was used by postpartum women to share their experience of taking ARVs. The research was analysed from an interpretative and critical paradigm where both the women and a non-governmental organisation collaborated in the data collection, analysis and interpretation of the findings. Together, they then disseminated the findings and used a community-led approach to create a programme addressing these barriers effectively. FINDINGS: Two main barriers to ARV adherence emerged: the anticipated stigma associated with issues of disclosure and poverty epitomized by alcohol abuse, gender-based violence and hunger. The women and the NGO staff successfully presented their findings at conferences and collaborated to develop a programme of support for all women living with HIV in the area. The programme addresses each of the issues raised by the co-researchers and is run via a community-led process where the participants lead on design, implementation, and monitoring and ultimately will revise the programme as needed. DISCUSSION: The inclusive approach of this study enabled these postpartum women to portray the intersectional nature of both HIV stigma and poverty that affects their lives. By working with the local NGO to develop a programme based on these insights, they were able to tailor specific interventions to the issues women living with HIV face in their area. In doing so, they aim to improve the lives of people living with HIV by demonstrating a more sustainable way to impact ARV adherence. CONCLUSION: Currently, health service insistence on measuring ARV adherence does not address the core barriers to taking ARVs and misses the opportunity to focus on the long term health and well-being of people living with HIV. In contrast, locally targeted participatory research and programme development based on inclusivity, collaboration and ownership do address the fundamental challenges of people living with HIV. In doing so, it can have a greater impact on their long term well-being.

HIV care coverage among HIV-positive adolescent girls and young women in South Africa: Results from the HERStory Study.

BACKGROUND: Health service coverage cascades measure the proportion of a population in need of a service that experienced a positive health outcome from the service, and enable tracking of progress in achieving universal health coverage and inequities in care coverage. OBJECTIVES: To investigate HIV care coverage among HIV-positive adolescent girls and young women (AGYW) living in six South African districts, compare coverage by age and socioeconomic status (SES), and investigate other associated factors including participation in a combination HIV prevention intervention. METHODS: The HERStory Study was an evaluation of the combination intervention, comprising a representative household survey of AGYW aged 15 - 24 years living in six intervention districts. From September 2017 to November 2018, biological, sociodemographic and behavioural data were collected. HIV-positive status, initiation of antiretroviral therapy (ART) and viral suppression were determined through laboratory tests (enzyme-linked immunosorbent assay for HIV antibodies, antiretroviral (ARV) metabolites and viral load (VL) testing). Viral suppression was defined as a VL <1 000 copies/mL. Knowledge of HIV-positive status was self-reported, and participants testing positive for ARV metabolites were assumed to have known their HIV-positive status. Unconditional HIV care cascades were created, stratified by age and SES. We used Pearson's χ2 tests corrected for survey-based analysis to describe factors associated with knowledge of HIV status, and being on ART. RESULTS: Of the 4 399 participants, 568 were HIV-positive (12.4%), of whom 60.8% (95% confidence interval (CI) 57.1 - 64.5) knew their status, 50.6% (95% CI 46.6 - 54.0) were on ART, and 62.1% (95% CI 58.4 - 65.9) were virally suppressed. Most participants (84.9%) were in the lower SES group, and they had better coverage than the higher SES group: 61.9% (95% CI 58.3 - 65.4) knew their status, 52.1% (95% CI 48.4 - 55.9) were on ART, and 64.9% (95% CI 61.3 - 68.4) were virally suppressed, compared with 55.0% (95% CI 42.1 - 68.0), 40.0% (95% CI 29.2 - 50.8), and 46.6% (95% CI 34.5 - 58.7), respectively. Participants aged 15 - 19 years had slightly inferior coverage to the 20 - 24-year-old group: 57.5% knew their status, 46.1% were on ART and 59.5% were virally suppressed, compared with 62.3%, 52.2% and 63.3%. CONCLUSIONS: These findings emphasise the need to close the gaps in HIV care coverage among AGYW, of whom only 61% knew their HIV-positive status and only 62% were virally suppressed. There is pro-poor inequality in HIV care coverage, with those in lower socioeconomic groups more likely to be virally suppressed.

Providers PrEP: Identifying Primary Health care Providers' Biases as Barriers to Provision of Equitable PrEP Services.

BACKGROUND: Despite their disparately high HIV incidence and voiced willingness to use pre-exposure prophylaxis (PrEP), Black cisgender women's knowledge and uptake of PrEP are low, especially relative to White cisgender women and men who have sex with men. Mounting evidence demonstrates that health care provider recommendations are a critical factor in women's awareness, willingness, and ability to uptake PrEP. Health care providers may make clinical judgments about who is (not) a good candidate for PrEP based on unconscious and conscious stereotypes and prejudice. SETTING: We conducted an online experiment among N = 160 health care providers with prescribing privileges in the 48 HIV hotspot counties. METHOD: Providers received 1 of 4 vignettes about a PrEP eligible woman. Vignettes varied by patient race and substance use status. Then, providers reported their willingness to discuss PrEP with the patient and willingness to prescribe PrEP to her. RESULTS: We tested 2 models predicting providers (1) willingness to discuss and (2) willingness to prescribe PrEP, contingent on their racial attitudes. Providers who scored high on a modern racism measure were less willing to discuss and prescribe PrEP to the Black patient. These effects were mediated by provider perceptions of patients' abilities to adhere to PrEP, but not their expectations of risk compensatory behaviors. CONCLUSIONS: Our findings highlight the importance of applying an intersectional lens in documenting the processes that exacerbate inequities in PrEP use. This study provides evidence to support the development of interventions that address the mechanisms that work to thwart optimal care.

Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial.

Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. This Viewpoint describes how we managed ethical issues over the duration of one of these trials (HPTN 083). Specifically, we discuss the rationale for pursuing a long-acting injectable agent in the presence of effective oral PrEP, trial design choices, site selection and local standards of prevention, data monitoring and early stopping, effects of the COVID-19 pandemic, post-trial access, and assessment of long-term safety.

Brief Report: HIV Pre-exposure Prophylaxis Prescribing in an Urban Safety-Net Health System.

INTRODUCTION: Safety-net health systems are key settings for HIV pre-exposure prophylaxis (PrEP) implementation, but little evidence is available about the frequency of PrEP prescribing in safety-net settings. We assessed PrEP prescribing among people with indications for PrEP at an urban safety-net health system that serves a county designated as an Ending the HIV Epidemic priority jurisdiction. METHODS: We identified adults (aged 18 years or older) who engaged in primary care between January 2015 and December 2019 and had a documented indication for PrEP. PrEP indications included the presence of a behavioral or sexual risk factor of HIV acquisition or a positive bacterial sexually transmitted infection at the index visit. PrEP prescribing was defined as the proportion of patients with indications for PrEP who received a new prescription for PrEP. We estimated the cumulative incidence of PrEP prescription with corresponding 95% confidence limits (CL). RESULTS: Our study population comprised 2957 individuals, of whom 58% was aged younger than 45 years, 56% was women, 67% was racial or ethnic minorities, and 60% was uninsured or provided care as part of a hospital-based managed care plan for individuals without insurance. We identified 41 individuals who were prescribed PrEP. The cumulative incidence of PrEP prescribing within 1 year of the first documented PrEP indication was 1.3% (95% CL: 0.91% to 1.7%). CONCLUSIONS: Our results suggest extremely low frequency of PrEP prescribing among people with indications for PrEP in an urban safety-net health system. Strategies are needed to improve PrEP implementation in high-priority populations and safety-net settings.

Point-of-Care Detection of Nonadherence to Antiretroviral Treatment for HIV-1 in Resource-Limited Settings Using Drug Level Testing for Efavirenz, Lopinavir, and Dolutegravir: A Validation and Pharmacokinetic Simulation Study.

BACKGROUND: Virological failure during antiretroviral treatment (ART) may indicate the presence of drug resistance, but may also originate from nonadherence. Qualitative detection of ART components using drug level testing may be used to differentiate between these scenarios. We aimed to validate and implement qualitative point-of-care drug level tests for efavirenz (EFV), lopinavir (LPV), and dolutegravir (DTG) in rural South Africa. METHODS: Qualitative performance of immunoassays for EFV, LPV, and DTG was assessed by calculating limit of detection (LoD), region of uncertainty, and qualitative agreement with a reference test. Minimum duration of nonadherence resulting in a negative drug level test was assessed by simulation of treatment cessation using validated population pharmacokinetic models. RESULTS: LoD was 0.05 mg/L for EFV, 0.06 mg/L for LPV, and 0.02 mg/L for DTG. Region of uncertainty was 0.01-0.06 mg/L for EFV, 0.01-0.07 mg/L for LPV, and 0.01-0.02 mg/L for DTG. Qualitative agreement with reference testing at the LoD in patient samples was 95.2% (79/83) for EFV, 99.3% (140/141) for LPV, and 100% (118/118) for DTG. After simulated treatment cessation, median time to undetectability below LoD was 7 days [interquartile range (IQR) 4-13] for EFV, 30 hours (IQR 24-36) for LPV, and 6 days (IQR 4-7) for DTG. CONCLUSIONS: We demonstrate that qualitative ART drug level testing using immunoassays is feasible in a rural resource-limited setting. Implementation of this technology enables reliable detection of recent nonadherence and may allow for rapid and cost-effective differentiation between patients in need for adherence counseling and patients who require drug resistance testing or alternative treatment.

Facilitators and barriers of 2-1-1 HIV pre-exposure prophylaxis.

An alternative strategy for men who have sex with men (MSM) experiencing challenges with daily HIV pre-exposure prophylaxis (PrEP) includes 2-1-1 dosing. Understanding 2-1-1 PrEP facilitators and barriers, especially during the SARS-CoV-2 pandemic, may guide researchers and healthcare providers in future studies and clinical preparedness. We conducted a national cross-sectional study of MSM in the US who had taken 2-1-1 PrEP to examine facilitators and barriers of this on-demand PrEP dosing option. With the shelter-in-place orders in March 2020, this study was adapted to include questions on how the SARS-CoV-2 pandemic affected participants' PrEP use. A total of 140 individuals participated in the survey, 106 of which completed questions pertaining to the SARS-CoV-2 pandemic. The most common reasons for switching from once-daily to 2-1-1 PrEP included having sex less frequently (63.6%) and wanting to take fewer pills (46.4%). Participants reported high medication adherence based on each component of 2-1-1 PrEP dosing (>84%). The most common barriers with 2-1-1 PrEP dosing included unplanned sexual encounters resulting in missing the double-dose pre-sex (43.6%) and trouble remembering doses post-sex (29.3%). Facilitators of the 2-1-1 PrEP dosing strategy included reductions in sexual encounters (63.6%), preference to take fewer pills (46.4%), need to reduce cost (22.1%), and desire to reduce side effects (19.3%). Challenges to receiving PrEP services during the pandemic included obtaining laboratory testing (25.5%) and PrEP refills (either receipt of a refill authorization from a healthcare provider or processing of a refill from the pharmacy) (18.9%). 2-1-1 PrEP is an effective HIV prevention method; therefore, understanding facilitators and barriers of this dosing strategy can result in continuous provision of HIV prevention efforts, particularly during a pandemic.

Cost of pre-exposure prophylaxis delivery in family planning clinics to prevent HIV acquisition among adolescent girls and young women in Kisumu, Kenya.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15-24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs. METHODS: We estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH). RESULTS: For the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario). CONCLUSIONS: Using data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.

Unmet need for family planning and associated factors among women living with HIV in Gondar city, Northwest Ethiopia: cross-sectional study.

INTRODUCTION: all women, including those living with HIV, have the right to choose the timing, spacing, and number of their births and need access to family planning services. This study aimed at assessing the prevalence and factors associated with an unmet need for family planning among women receiving Antiretroviral Therapy (ART) services. METHODS: a facility-based cross-sectional study was conducted from March to April 2018 in Gondar city, Ethiopia. A systematic random sampling technique was used to recruit 441 reproductive-age women on ART. The data were collected using a pretested structured questionnaire. The bivariate and backward multivariable logistic regression model was fitted to identify factors associated with the unmet need for family planning. RESULTS: the prevalence of the unmet need for family planning among women living with HIV was 24.5%. Increase in women´s age (AOR: 0.90, 95% CI (0.85, 0.95)), having more than three children (AOR: 0.13, 95% CI (0.04, 0.38)), intention to have more children (AOR: 0.09, 95% CI (0.03, 0.23)), not disclosing sero-status to partner (AOR: 0.40, 95% CI (0.20, 0.82)) and having no experience of contraception use (AOR: 0.43, 95% CI (0.21, 0.90)) were protective factors against unmet need for family planning. Rural residence (AOR: 2.17, 95% CI (1.05, 4.46)) was associated with increased odds of unmet need for family planning. CONCLUSION: one in every four women living with HIV had an unmet need for family planning. So, continuous awareness-raising activities on family planning for women on ART should be given by emphasizing the rural and younger age women.

The potential role of long-acting injectable cabotegravir-rilpivirine in the treatment of HIV in sub-Saharan Africa: a modelling analysis.

BACKGROUND: The use of a combination of the integrase inhibitor, cabotegravir, and the non-nucleoside reverse transcriptase inhibitor, rilpivirine, in a long-acting injectable form is being considered as an antiretroviral treatment option for people with HIV in sub-Saharan Africa. We aimed to model the effects of injectable cabotegravir-rilpivirine to help to inform its potential effectiveness and cost-effectiveness under different possible policies for its introduction. METHODS: We used an existing individual-based model of HIV to predict the effects of introducing monthly injections of cabotegravir-rilpivirine for people with HIV in low-income settings in sub-Saharan Africa. We evaluated policies in the context of 1000 setting scenarios that reflected characteristics of HIV epidemics and programmes in sub-Saharan Africa. We compared three policies for introduction of injectable cabotegravir-rilpivirine with continued use of dolutegravir-based oral regimens for: all individuals on antiretroviral therapy (ART); individuals with a recently measured viral load of more than 1000 copies per mL (signifying poor adherence to oral drugs, and often associated with drug resistance); and individuals with a recently measured viral load of less than 1000 copies per mL (a group with a lower prevalence of pre-existing drug resistance). We also did cost-effectiveness analysis, taking a health system perspective over a 10 year period, with 3% discounting of disability-adjusted life-years (DALYs) and costs. A cost-effectiveness threshold of US$500 per DALY averted was used to establish if a policy was cost-effective. FINDINGS: In our model, all policies involving the introduction of injectable cabotegravir-rilpivirine were predicted to lead to an increased proportion of people with HIV on ART, increased viral load suppression, and decreased AIDS-related mortality, with lesser benefits in people with a recently measured viral load of less than 1000 copies per mL. Its introduction is also predicted to lead to increases in resistance to integrase inhibitors and non-nucleoside reverse transcriptase inhibitors if introduced in all people with HIV on ART or in those with a recently measured viral load of less than 1000 copies per mL, but to a lesser extent if introduced in people with more than 1000 copies per mL due to concentration of its use in people less adherent to oral therapy. Consistent with the effect on AIDS-related mortality, all approaches to the introduction of injectable cabotegravir-rilpivirine are predicted to avert DALYs. Assuming a cost of $120 per person per year, use of this regimen in people with a recently measured viral load of more than 1000 copies per mL was borderline cost-effective (median cost per DALY averted across setting scenarios $404). The other approaches considered for its use are unlikely to be cost-effective unless the cost per year of injectable cabotegravir-rilpivirine is considerably reduced. INTERPRETATION: Our modelling suggests that injectable cabotegravir-rilpivirine offers potential benefits; however, to be a cost-effective option, its introduction might need to be carefully targeted to individuals with HIV who might otherwise have suboptimal adherence to ART. As data accumulate from trials and implementation studies, such findings can be incorporated into the model to better inform on the full consequences of policy alternatives. FUNDING: Bill & Melinda Gates Foundation, including through the HIV Modelling Consortium (OPP1191655).

Barriers and motivators to pre-exposure prophylaxis uptake among Black and Latina transgender women in Los Angeles: perspectives of current PrEP users.

The purpose of this qualitative study was to identify barriers and motivators to PrEP uptake from the perspective of Black and Latina transgender women (TW) who are currently using PrEP to suggest intervention and outreach activities to increase PrEP uptake in this population. The Information-Motivation-Behavioral Skills Model guided the development of the semi-structured interview guide. A thematic analysis approach was used to analyze the data. Perceived barriers to PrEP uptake included structural and logistic barriers, language and cultural barriers to medical engagement, lack of transgender competent or gender-affirming care, and prioritizing hormone therapy over the use of PrEP. To increase PrEP uptake among BLTW, participants recommended disseminating PrEP information through a variety of methods, highlighting relationship and sexual health benefits of using PrEP, and developing effective patient-provider communication. Our findings highlight several ways to promote PrEP among BLTW. PrEP promotion should be integrated into gender-affirming care and supported by peer education and navigation services that reach BLTW in both clinic and community settings.

Exploration of the Complex Relationships Among Multilevel Predictors of PrEP Use Among Men Who Have Sex with Men in the United States.

To explore the relationships among individual-, social-, and contextual- (state-level characteristics, including LBGTQ + and racial inequality) level factors and PrEP use. A cross-sectional survey was conducted in 2015-2016 among a geographically diverse group of men who have sex with men (MSM). Survey data was linked to publicly available state-level data based on participant zip code. Multivariable multilevel logistic regression was used to explore the association between multilevel variables and PrEP use. Of 4165 HIV-negative MSM, 13.4% were taking PrEP. In the regression analysis, several demographic and behavioral factors were associated with higher odds of PrEP use. Importantly, after adjusting for individual- and social-level factors, residents of states with high LGBTQ + equality had significantly higher odds of taking PrEP (OR 1.57; 95% CI 1.119, 2.023) compared to low equality states. LGBTQ + inequality between states may hinder PrEP use. States may need to take proactive measures to reduce LGBTQ + inequality as this may negatively impact the ability to reach the federal administration's stated goal to end the HIV epidemic in the US.

Socio-economic condition and lack of virological suppression among adults and adolescents receiving antiretroviral therapy in Ethiopia.

INTRODUCTION: The potential impact of socio-economic condition on virological suppression during antiretroviral treatment (ART) in sub-Saharan Africa is largely unknown. In this case-control study, we compared socio-economic factors among Ethiopian ART recipients with lack of virological suppression to those with undetectable viral load (VL). METHODS: Cases (VL>1000 copies/ml) and controls (VL<150 copies/ml) aged ≥15years, with ART for >6 months and with available VL results within the last 3 months, were identified from registries at public ART clinics in Central Ethiopia. Questionnaire-based interviews on socio-economic characteristics, health condition and transmission risk behavior were conducted. Univariate variables associated with VL>1000 copies/ml (p<0.25) were added to a multivariable logistic regression model. RESULTS: Among 307 participants (155 cases, 152 controls), 61.2% were female, and the median age was 38 years (IQR 32-46). Median HIV-RNA load among cases was 6,904 copies/ml (IQR 2,843-26,789). Compared to controls, cases were younger (median 36 vs. 39 years; p = 0.004), more likely to be male (46.5% vs. 30.9%; p = 0.005) and had lower pre-ART CD4 cell counts (170 vs. 220 cells/µl; p = 0.009). In multivariable analysis of urban residents (94.8%), VL>1000 copies/ml was associated with lower relative wealth (adjusted odds ratio [aOR] 2.98; 95% CI 1.49-5.94; p = 0.016), geographic work mobility (aOR 6.27, 95% CI 1.82-21.6; p = 0.016), younger age (aOR 0.94 [year], 95% CI 0.91-0.98; p = 0.011), longer duration of ART (aOR 1.19 [year], 95% CI 1.07-1.33; p = 0.020), and suboptimal (aOR 3.83, 95% CI 1.33-10.2; p = 0.048) or poor self-perceived wellbeing (aOR 9.75, 95% CI 2.85-33.4; p = 0.012), after correction for multiple comparisons. High-risk sexual behavior and substance use was not associated with lack of virological suppression. CONCLUSION: Geographic work mobility and lower relative wealth were associated with lack of virological suppression among Ethiopian ART recipients in this predominantly urban population. These characteristics indicate increased risk of treatment failure and the need for targeted interventions for persons with these risk factors.