Attitudes toward scale-up of an Intensive Combination Approach to Rollback the Epidemic in Nigerian adolescents (iCARE) intervention for youth in Nigeria: results of a mixed methods early-implementation study.

Background: Youth living with HIV (YLH) are disproportionately impacted by HIV with poor outcomes along the entire HIV care continuum. In a 2020-2022 pilot study, iCARE Nigeria, successfully tested a combination intervention incorporating mobile health technology and peer navigation to: 1) improve testing and linkage to HIV care for young men, especially young men who have sex with men (YMSM) and 2) improve medication adherence and treatment outcomes for YLH. The intervention was scaled up to 5 sites in 3 Nigerian cities.

A Stepped-Wedge, Cluster-Randomized, Multisite Study of Text Messaging Plus Peer Navigation to Improve Adherence and Viral Suppression Among Youth on Antiretroviral Therapy.

Background: To address the need for improved virologic suppression among youth living with HIV (YLH) on antiretroviral treatment (ART), we evaluated peer navigation plus TXTXT daily text message ART reminders.

Setting: YLH aged 15-24 years on ART for at least 3 months at 6 research sites in 4 Nigerian cities.

Methods: Using a stepped-wedge design, cluster 1 was nonrandomized, whereas clusters 2 and 3 were randomized to sequences of routine care (control period) and 48 weeks of the combination intervention (intervention period).

Successful Implementation Strategies in iCARE Nigeria-A Pilot Intervention with Text Message Reminders and Peer Navigation for Youth Living with HIV.

To address poor outcomes among adolescents and young adults living with HIV (AYA-HIV), iCARE Nigeria successfully piloted two-way text message antiretroviral therapy (ART) reminders together with peer navigation. Study participants had significant improvement in ART adherence and viral suppression at 48 weeks. Understanding facto of this intervention.

A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.

Background: Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria.

Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.

Background: Neurocognitive impairment (NCI) in people with HIV (PWH) on antiretroviral therapy (ART) is common and may result from persistent HIV replication in the central nervous system.

Methods: A5324 was a randomized, double-blind, placebo-controlled, 96-week trial of ART intensification with dolutegravir (DTG) + MVC, DTG + Placebo, or Dual - Placebo in PWH with plasma HIV RNA <50 copies/mL on ART and NCI. The primary outcome was the change on the normalized total z score (ie, the mean of individual NC test z scores) at week 48.

No difference in anti-spike antibody and surrogate viral neutralization following SARS-CoV-2 booster vaccination in persons with HIV compared to controls (CO-HIV Study).

Background: Understanding the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination will enable accurate counseling and inform evolving vaccination strategies. Little is known about antibody response following booster vaccination in people living with HIV (PLWH).

Methods: We enrolled SARS-CoV-2 vaccinated PLWH and controls without HIV in similar proportions based on age and comorbidities.

The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial.

Background: REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality.

Comparison of efavirenz levels in blood and hair with pharmacy refills as measures of adherence and predictors of viral suppression among people living with HIV in Nigeria.

Background: Strategies to support adherence are constrained by the lack of tools to objectively monitor medication intake in low-resource settings. Pharmacologic measures are objective, but pharmacy refill data is more accessible and cost-efficient. This study compared short-term and long-term efavirenz (EFV) drug levels with pharmacy refill adherence data (PRA) and evaluated their ability to predict viral suppression among people living with HIV in Nigeria.

Post-migration HIV acquisition among african immigrants in the U.S.

Background: African immigrants in the U.S. are more likely to have a late HIV diagnosis than U.

Evaluation of the iCARE Nigeria Pilot Intervention Using Social Media and Peer Navigation to Promote HIV Testing and Linkage to Care Among High-Risk Young Men: A Nonrandomized Controlled Trial.

Importance: Nigeria has the fourth-largest HIV epidemic globally, yet high levels of social stigma inhibit HIV testing among Nigerian youths and young men who have sex with men (MSM).

Objective: To report pilot data from iCARE Nigeria (Intensive Combination Approach to Roll Back the Epidemic in Nigerian Adolescents), a combination intervention using social media and peer navigation to promote HIV testing and linkage to care among high-risk youths and young men (hereinafter referred to as young men), including predominantly young MSM.

Design, Setting, And Participants: This nonrandomized controlled study assessed an organizational and community-level 12-month, preintervention-postintervention pilot trial of a combination intervention designed to increase HIV testing uptake, increase the rate of identified seropositive cases, and improve linkage to care among young men, including MSM, using social media outreach and peer navigation.

Adaptation of evidence-based approaches to promote HIV testing and treatment engagement among high-risk Nigerian youth.

Background: Nigeria has the second highest number of people living with HIV (PLWH) globally, and evidence-based approaches are needed to achieve national goals to identify, treat, and reduce new infections. Youth between the ages of 15-24, including young men who have sex with men (YMSM), are disproportionately impacted by the Nigerian HIV epidemic. The purpose of this study was to inform adaptation of evidence-based peer navigation and mHealth approaches (social media outreach to promote HIV testing; short messaging service text message reminders to promote HIV treatment engagement) to the local context within iCARE Nigeria, a multi-phase study designed to investigate combination interventions to promote HIV testing and care engagement among youth in Nigeria.

Effect of Text Messaging Plus Peer Navigation on Viral Suppression Among Youth With HIV in the iCARE Nigeria Pilot Study.

Background: Consistent with the global trend, youth with HIV (YWH) in Nigeria have high rates of viral nonsuppression. Hence, novel interventions are needed.

Setting: Infectious Diseases Institute, College of Medicine, University of Ibadan, Nigeria.

Pharmacogenetic interactions between antiretroviral drugs and vaginally administered hormonal contraceptives.

Objective: In AIDS Clinical Trials Group study A5316, efavirenz lowered plasma concentrations of etonogestrel and ethinyl estradiol, given as a vaginal ring, while atazanavir/ritonavir increased etonogestrel and lowered ethinyl estradiol concentrations. We characterized the pharmacogenetics of these interactions.

Methods: In A5316, women with HIV enrolled into control (no antiretrovirals), efavirenz [600 mg daily with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)], and atazanavir/ritonavir (300/100 mg daily with NRTIs) groups.

Baseline 10-Year Cardiovascular Risk Scores Predict Cognitive Function in Older Persons, and Particularly Women, Living With Human Immunodeficiency Virus Infection.

Background: Cardiovascular disease (CVD) and associated comorbidities increase the risk of cognitive impairment in persons living with human immunodeficiency virus (PLWH). Given the potential composite effect of multiple cardiovascular risk factors on cognition, we examined the ability of the Atherosclerotic Cardiovascular Disease (ASCVD) risk score and the Framingham Heart Study Global CVD risk score (FRS) to predict future cognitive function in older PLWH.

Methods: We constructed linear regression models evaluating the association between baseline 10-year cardiovascular risk scores and cognitive function (measured by a summary z-score, the NPZ-4) at a year 4 follow-up visit.

Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.

Background: Drug-drug interactions between orally administered antiretroviral therapy (ART) and hormones released from an intravaginal ring are not known. We hypothesised that ART containing either efavirenz or ritonavir-boosted atazanavir would alter plasma concentrations of vaginally administered etonogestrel and ethinylestradiol but that ART concentrations would be unchanged during use of an intravaginal ring.

Methods: We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016.

HIV stigma and viral load among African-American women receiving treatment for HIV.

Objective: African-American women are more likely than other women in the United States to experience poor HIV-related health; HIV stigma may contribute to these outcomes. This study assessed the relationship between HIV stigma and viral load, over time, among a sample of African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators.

Design: Secondary analysis of longitudinal data.

Willingness to Donate Hair Samples for Research Among People Living with HIV/AIDS Attending a Tertiary Health Facility in Ibadan, Nigeria.

The use of hair samples in biomedical research is a rapidly growing field. High acceptability rates for hair collection have been demonstrated in multiple settings. Each setting may have unique issues and, to our knowledge, no previous study has assessed the acceptability of hair sampling for HIV-related research in Nigeria.

Comparable viral decay with initial dolutegravir plus lamivudine versus dolutegravir-based triple therapy.

Objectives: To expand understanding of the virological potency of initial dolutegravir plus lamivudine dual therapy (dolutegravir/lamivudine), we compared the viral decay seen in the pilot ACTG A5353 study with the decay observed with dolutegravir plus two NRTIs in the SPRING-1 and SINGLE studies, while also exploring the impact of baseline viral load (VL).

Methods: Change in VL from baseline was calculated for timepoints shared by A5353 (n = 120, including 37 participants with pretreatment VL >100000 copies/mL), SPRING-1 (n = 51) and SINGLE (n = 417). The 95% CIs of change from baseline were determined for each observed week, using the mean log10-transformed VL, and compared between the dolutegravir/lamivudine and triple therapy groups using the Wilcoxon Rank Sum test for non-inferiority (δ = 0.

No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial.

In the ASPIRE trial, antiretroviral therapy (ART) switch to dolutegravir plus lamivudine (DTG+3TC) was comparable to 3-drug ART in maintaining viral suppression by standard viral load assays. We used an ultrasensitive assay to assess whether this switch led to increased residual viremia. At entry, levels of residual viremia did not differ significantly between arms (DTG+3TC vs 3-drug ART: mean, 5.

Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353.

Background: The AIDS Clinical Trials Group study A5353 demonstrated the efficacy and safety of dolutegravir and lamivudine for initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA 1000-500 000 copies/mL. Optimal ART for treatment-naive individuals must be durable.

Objectives: The aim of this study was to estimate the efficacy and safety of dolutegravir plus lamivudine at week 48 and compare the efficacy in participants with baseline HIV-1 RNA ≤100 000 copies/mL versus >100 000 copies/mL.