There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend or partner of the patient) can help mitigate some of these patient-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence.

INVITE-Home (innovative administration of long-acting injectables for HIV treatment enhancement at home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.

This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV.

NCT06488846.

To assess the quality of amoxicillin products in Indonesia’s private market by surveying the range of products available across different areas, followed by product sampling and laboratory testing.

A cross-sectional survey employing mystery shoppers to purposively sample the widest possible range of amoxicillin products available to patients across different areas in Indonesia.

Licensed and unlicensed medicine outlets in remote, rural and urban areas and online.

Amoxicillin products that are sold to patients as oral solid and dry liquid formulations.

Quality of amoxicillin products, assessed using compendial testing of active pharmaceutical ingredient content and dissolution. Samples that failed any quality test were classified as substandard or out-of-specification (OOS). The raw prevalence of substandard amoxicillin was adjusted based on the national market volume of each product variant.

We surveyed 476 outlets, mostly pharmacies (68.5%), websites (19.7%) and drug stores (10.9%). Among the 120 collected samples, there were 59 distinct products, collectively representing 95% of the estimated market volume for oral solid products and 65% for dry syrups. 12 out of 110 oral solid samples tested OOS (10.9%), as did 3 out of 10 dry syrups (30%). The samples that failed originated from various areas and types of outlets. We found no relation between the price and quality of amoxicillin.

The oral solid amoxicillin products that tested OOS represent an estimated 12.7% of the national market volume. We found no relation between the price and quality of amoxicillin. Combining product-variety sampling with data on market volume presents a promising approach to gain insight into the prevalence of poor-quality medical products using a relatively small sample size.