Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho

Study Overview
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Brief Summary
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This cluster-randomized trial tests a differentiated care model for HIV-positive individuals not on ART during a home-based HIV testing campaign in rural Lesotho, Southern Africa. In intervention clusters, patients are offered a differentiated ART delivery package with two features. Firstly, drug-refill and follow-up are provided by village health workers (VHW), reducing clinic visits to twice a year for laboratory assessment. Secondly, participants have the option of receiving individually tailored adherence reminders and viral load result notifications via SMS.

Detailed Description
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The VIBRA trial is a cluster randomized controlled, open-label, superiority trial in a resource-limited setting. The trial is linked to a another trial, the HOSENG (HOme-based SElf-testiNG) trial, that is described elsewhere (NCT03598686). Together, they consitute the GET ON (GETing tOwards Ninety) research project. The HOSENG study, with its home-based HIV testing campaign, provides the recruitment platform for the VIBRA study. The reasons for this interlinked design are: a) potential study participants for VIBRA trial (HIV-positive individuals not on ART) are to be recruited during a home-based HIV testing campaign and hence, it allows us to assess the entire HIV care cascade in one larger project, and b) both trials rely on interventions involving VHWs, who need to be randomized and specifically trained. Therefore, it is efficient and feasible to run both trials parallel and randomize at one time point only. The rational for a cluster randomized design is the reliance of the trial on the VHWs and, thus, the high risk of cross-contamination between the study arms if randomization would be done at individual level.

Official Title
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Village-based Refill of ART After Same-day ART Start vs Clinic-based ART Refill for HIV-positive Individuals Not on ART During Home-based HIV Testing (Part B of GET ON Research Project)

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Standard of Care
* Other: Village-based ART refill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for clusters: the cluster is clearly confined to the catchment area of one of the study clinics the cluster has at least one registered VHW who is willing to participate and fulfills the following criteria: is at least 18 years of age has adequate reading and writing skills successfully passes the training assessment village authority (village chief) is willing to participate in trial Exclusion criteria for clusters: Village authority (=village chief) opposed to trial participation (verbal assent) Village health worker opposed to trial participation or not fulfilling the minimum requirements mentioned above Inclusion Criteria for individuals: Individual is a household member of the visited households of the respective clusters Individual is confirmed HIV-positive Individual has never taken ART (ART-naïve) or has stopped ART more than 30 days prior (ART-defaulters) Individual is ≥10 years old and has a body weight of ≥35kg Individual is not in care for high blood pressure or diabetes (high blood sugar) HIV-positive individual wishes to get care outside the study districts Exclusion criteria individuals: The household member is absent at the time of the campaign HIV-positive individual is taking ART or stopped less than 30 days ago HIV-positive individual is physically, mentally, or emotionally not able to participate in the study, in the opinion of the investigators or study staff HIV-positive individual is in care for high blood pressure (hypertension) or high blood sugar (diabetes) - proof of documentation or medication needed HIV-positive individual wishes to get care outside the study districts

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel cluster-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Offer of home-based same-day ART initiation Clinic-based ART visit/refill Who: Nurse Where: Nurse-led health facility When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing No SMS intervention | Other: Standard of Care<br>* Clinic-based HIV care<br>|
| Experimental: Village-based ART refill<br>Offer of home-based same-day ART initiation Offer of Village-based ART visit/refill Who: VHW Where: At VHW's home* When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing *Except at 6 and 12 months follow-up: visit at health facility for laboratory assessment (viral load) Offer of Individually customized SMS Monthly reminder SMS: to pick up ART SMS communicating VL result | Other: Village-based ART refill<br>* Option to get ART refill and care by the village health worker<br>* Other names: VIBRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-months viral suppression | Viral suppression at 12 months, defined as the proportion of all participants with a VL <20 copies/mL | 12 months (range: 10 - 15 months) after enrolment. | 
| 12-months viral suppression (<400copies/mL) | Viral suppression at 12 months, defined as the proportion of all participants with a VL <400 copies/mL | 12 months (range: 10 - 15 months) after enrolment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-months viral suppression | Viral suppression at 6 months, defined as the proportion of all participants with a VL <20 copies/mL | 6 months (range 5 - 8 months) after enrolment | 
| Alternative viral suppression at 12 months | The proportion of all participants with a VL <1000 copies/mL | 12 months (range 10 - 15 months) after enrolment. | 
| Alternative viral suppression at 6 months | The proportion of all participants with a VL <1000 copies/mL | 6 months (range 5 - 8 months) after enrolment | 
| Sustained viral suppression | The proportion of all participants with a VL <20 copies/mL at 6 (range 5 - 8 months) as well as at 12 months (range 10 - 15 months) after enrolment | 12 months (range 5 - 15 months) after enrollment | 
| 1-month linkage to care | Linkage to care within 1 month, defined as the proportion of all participants attending the first clinic- or VHW-based ART visit at least once within 1 month after enrolment | 30 days after enrollment | 
| 3-months linkage to care | Linkage to care within 3 months, defined as the proportion of all participants attending the first clinic- or VHW-based ART visit at least once within 3 months after enrolment | 90 days | 
| 6-months retention in care | The proportion of all participants active in care at a health facility or at the VHW 6 months (range 5 - 8 months) after enrollment | 5-8 months after enrollment | 
| 12-months retention in care | the proportion of all participants active in care at a health facility or at the VHW | 12 months (range 10 - 15 months) after enrolment | 
| All-cause mortality at 12 months | The proportion of all participants who died | 12 months (range 10 - 15 months) after enrolment | 
| Loss to follow-up at 12 months | The proportion of all participants lost to follow-up | 12 months (range 10 - 15 months) after enrollment | 
| Confirmed transfer out at 12 months | The proportion of all participants who transferred out to any other health facility (than the one initially registered) outside the study districts with a proof of transfer (documented proof of follow-up visit or laboratory test) | 12 months (range 10 - 15 months) after enrolment | 
| Unconfirmed transfer out at 12 months | The proportion of all participants who transferred out to any other health facility (than the one initially registered) outside the study districts without a proof of transfer at 12 months (range 10 - 15 months) after enrolment | 12 months (range 10 - 15 months) after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy