Background Late initiation of HIV antiretroviral therapy (ART) in pregnancy is associated with not achieving viral suppression before giving birth and increased mother-to-child transmission of HIV. We aimed to investigate virological suppression before giving birth with dolutegravir compared with efavirenz, when initiated during the third trimester. MethodsIn this randomised, open-label trial, DolPHIN-2, we recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester. Participants were randomly assigned (1:1) to dolutegravir-based or efavirenz-based therapy. HIV viral load was measured 7 days and 28 days after antiretroviral initiation, at 36 weeks' gestation, and at the post-partum visit (0-14 days post partum). The primary efficacy outcome was a viral load of less than 50 copies per mL at the first post-partum visit, and the primary safety outcome was the occurrence of drug-related adverse events in mothers and infants until the post-partum visit. Longer-term follow-up of mothers and infants continues. This study is registered with ClinicalTrials.gov, NCT03249181.Findings Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or efavirenz (133). All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses. The median duration of maternal therapy at birth was 55 days (IQR 33-77). 89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1•64, 95% CI 1•31-2•06). 30 (22%) of 137 mothers in the dolutegravir group reported serious adverse events compared with 14 (11%) of 131 in the efavirenz group (p=0•013), particularly surrounding pregnancy and puerperium. We found no differences in births less than 37 weeks and less than 34 weeks gestation (16•4% vs 3•3%, across both groups). Three stillbirths in the dolutegravir group and one in the efavirenz group were considered unrelated to treatment. Three infant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-utero transmissions.Interpretation Our data support the revision to WHO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardless of pregnancy or child-bearing potential.Funding Unitaid.

Introduction HIV self‐testing is a flexible, accessible and acceptable emerging technology with a particular potential to identify people living with HIV who are reluctant to interact with conventional HIV testing approaches. We assessed the acceptability, perceived reliability and challenges associated with distributing HIV self‐test (HIVST) to young men who have sex with men (MSM) in Uganda. Methods Between February and May, 2018, we enrolled 74 MSM aged ≥18 years purposively sampled and verbally consented to participate in six focus group discussions (FGDs) in The AIDS Support Organization (TASO Masaka and Entebbe). We also conducted two FGDs of 18 health workers. MSM FGD groups included individuals who had; (1) tested greater than one year previously; (2) tested between six months and one year previously; (3) tested three to six months previously; (4) never tested. FGDs examined: (i) the acceptability of HIVST distribution; (iii) preferences for various HIVST distribution channels; (iv) perceptions about the accuracy of HIVST; (v) challenges associated with HIVST distribution. We identified major themes, developed and refined a codebook. We used Nvivo version 11 for data management. Results MSM participants age ranged between 19 and 30 years. Participants described HIVST as a mechanism that would facilitate HIV testing uptake in a rapid, efficient, confidential, non‐painful; and non‐stigmatizing manner. Overall, MSM preferred HIVST to the conventional HIV testing approaches. Health workers were in support of distributing HIVST kits through MSM peers. MSM participants were willing to distribute the kits and recommended HIVST to their peers and sexual partners. They suggested HIVST kit distribution model work similarly to the current condom and lubricant peer model being implemented by TASO. Preferred channels were peers, hot spots, drop‐in centres, private pharmacies and MSM friendly health facilities. Key concerns regarding use of HIVST were; unreliable HIVST results, social harm due to a positive result, need for a confirmatory test and linking both HIV positive and negative participants for additional HIV services. Conclusions Distribution of HIVST kits by MSM peers is an acceptable strategy that can promote access to testing. HIVST was perceived by participants as beneficial because it would address many barriers that affect their acceptance of testing. However, a combined approach that includes follow‐up, linkage to HIV care and prevention services are needed for effective results.

Background Adherence to treatment is critical for successful treatment outcomes. Although factors influencing antiretroviral therapy (ART) adherence vary, young adults are less likely to adhere owing to psychosocial issues such as stigma, ART-related side effects, and a lack of access to treatment. The Call for Life Uganda (CFLU) mobile health (mHealth) tool is a mobile phone–based technology that provides text messages or interactive voice response functionalities through a web interface and offers 4 modules of support. Objective This study aims to describe the acceptability and feasibility of a mobile phone support tool to promote adherence to ART among young adults in a randomized controlled trial. Methods An exploratory qualitative design with a phenomenological approach at 2 study sites was used. A total of 17 purposively selected young adults with HIV infection who had used the mHealth tool CFLU from 2 clinics were included. In total, 11 in-depth interviews and 1 focus group discussion were conducted to examine the following topics: experience with the CFLU tool (benefits and challenges), components of the tool, the efficiency of the system (level of comfort, ease, or difficulty in using the system), how CFLU resolved adherence challenges, and suggestions to improve CFLU. Participants belonged to 4 categories of interest: young adults on ART for the prevention of mother-to-child transmission, young adults switching to or on the second-line ART, positive partners in an HIV-discordant relationship, and young adults initiating the first-line ART. All young adults had 12 months of daily experience using the tool. Data were analyzed using NVivo version 11 software (QSR International Limited) based on a thematic approach. Results The CFLU mHealth tool was perceived as an acceptable intervention; young adults reported improvement in medication adherence, strengthened clinician-patient relationships, and increased health knowledge from health tips. Appointment reminders and symptom reporting were singled out as beneficial and helped to address the problems of forgetfulness and stigma-related issues. HIV-related stigma was reported by a few young people. Participants requested extra support for scaling up CFLU to make it more youth friendly. Improving the tool to reduce technical issues, including network outages and a period of software failure, was suggested. They suggested that in addition to digital solutions, other support, including the promotion of peer support meetings and the establishment of a designated space and staff members for youth, was also important. Conclusions This mHealth tool was an acceptable and feasible strategy for improving ART adherence and retention among young adults in resource-limited settings. Trial Registration ClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080

Background: In the era of rapid dolutegravir rollout, concerns about neural tube defects have complicated the health systems response among women of childbearing potential. This qualitative study, which was nested within the DolPHIN-2 clinical trial, examined the current and future health system opportunities and challenges associated with the transition to dolutegravir-based regimen as first line antiretroviral therapy among women of childbearing potential in South Africa and Uganda. Method: Semi-structured in-depth interviews with members of antiretroviral therapy guideline development groups and affiliates were conducted. Thirty-one participants were purposively selected for the study, including senior officials from the Ministry of Health and National Drug Regulatory Authority in Uganda and South Africa as well as health-sector development partners, activists, researchers and health workers. A thematic approach was used to analyse the data. Findings: Despite differences in health system contexts, several common challenges and opportunities were identified with the transition among women of childbearing potential in South Africa and Uganda. In both contexts national stakeholders identified challenges with ensuring gender equity in roll out due to the potential teratogenicity of dolutegravir, paucity of data on dolutegravir use in pregnancy, potential stock out of effective contraceptives, poorly integrated contraception services, and limited pharmacovigilance in pregnancy. Participants identified opportunities that could be harnessed to accelerate the transition, including high stakeholder interest and commitment to transition, national approval and licensure of a generic tenofovir/lamivudine/dolutegravir regimen, availability of a network of antiretroviral therapy providers, and strong desire among women for newer and more tolerable regimens.