An interventional study of Three monthly ART supply at CAGs and Six monthly ART supply at outreaches in HIV/AIDS, sponsored by Equip, Lesotho. Status unknown at 1 site in Lesotho. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Equip, Lesotho · Not applicable, Interventional, and Health services research
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals.
Methods
A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows:
The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load \<1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants.
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months.
The secondary outcomes are:
Background In 2015, sub-Saharan Africa was still the region most affected by the HIV epidemic, with 25.6 (23.1-28.5) million people living with HIV in 2015. It is estimated that 42% of all people living with HIV (PLHIV) in Lesotho were receiving ART by 2015.The United States Government's President's Emergency Plan for AIDS Relief (PEPFAR) has adopted the goals of 90-90-90 from UNAIDS, and is supporting a swift implementation of the new World Health Organization'sTest and Start guidelines.With these goals, PEPFAR also sets out to reduce new infections by 75% and to attain zero discrimination and stigma for all PLHIV.
To assist countries to reach the goal of universal coverage, EQUIP Innovation for health (a new field support award from the USAID Office of HIV and AIDS that supports innovations in HIV clinical and community-based HIV treatment related services) is evaluating communitybased care, treatment and support models to create an enabling environment for massive scale-up of ART delivery and adherence support. Based on this background, EQUIP and and Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) propose to conduct operational research that seeks to understand and measure the effectiveness of implementing a package of services that include multi-month dispensing (MMD) of ART drugs, Community ART distribution models through Community ART Groups (CAGs) and Community Distribution points and routine viral load monitoring of stable patients in communities of PEPFAR/USAID Lesotho scale-up districts.
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals.
Methods
A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows:
Sites for inclusion in the study will be selected at which it is deemed to be feasible to implement multi-month dispensing of ART in the community.
The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load \<1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants. For those sites randomized to the 3MC arm, enrolled participants will be part of a CAG for the duration of the study. For those sites randomized to the 6MCD arm, enrolled participants will be dispensed a 6-month supply of ART in the community by a healthcare worker in between their annual clinical assessments. All participants will have a clinical assessment and viral load testing at the clinic at least annually, and participants will be followed-up for 24 months after enrolment.
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months.
The secondary outcomes are:
Qualitative research will include assessing the acceptability of multi-month dispensing of ART within CAGs and the community from both a patient and healthcare provider perspective. Costs to patients will be compared between the three arms from data derived from patient surveys. In addition, indicators of potential facility level decongestion will be compared between arms, which will include the median facility patient waiting time and average monthly number of patients newly initiated on ART, with data derived from site surveys and routine facility-level data.
This study will follow the ethical considerations specified by the Lesotho National Health Research and Ethics Committee.
The results of the study are expected to inform health policy both nationally and regionally regarding the effectiveness of implementing a package of services consisting of MMD within CAGs and community distribution together with viral load monitoring for stable ART patients.
Exclusion Criteria:
Sites at which patients will be provided three monthly ART supply at health facilities.
Sites at which patients will be provided three monthly ART supply at Community ART Groups (CAGs).
Other: Three monthly ART supply at CAGs
Sites at which patients will be provided six monthly ART supply at Community distribution points or outreaches.
Other: Six monthly ART supply at outreaches
Sites where three monthly ART supply will be provided at outreaches
Sites where six monthly ART will supply will be provided at outreaches
retention in care
The proportion of patients remaining in care 12 months after study enrolment
Time frame: 12 months
Viral suppression
The proportion of patients with virological suppression (\<1000 copies/ml) 12 months after study enrolment
Time frame: 12 months
Cost of providing ART
The cost per patient of providing ART in each of the three arms (from a provider perspective)
Time frame: 12 months
Cost of retaining a patient
The provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms
Time frame: 12 months
Plan to share: Undecided
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→