Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho
- Conditions
- HIV/AIDS
- Interventions
- Other: Standard of CareOther: Village-based ART refill
- Registration Number
- NCT03630549
- Lead Sponsor
- Niklaus Labhardt
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Standard of Care 1. Offer of home-based same-day ART initiation 2. 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 3. No SMS intervention Village-based ART refill Village-based ART refill 1. Offer of home-based same-day ART initiation 2. 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) 3. Offer of Individually customized SMS * Monthly reminder SMS: to pick up ART * SMS communicating VL result
- Primary Outcome Measures
Name Time Method 12-months viral suppression 12 months (range: 10 - 15 months) after enrolment. Viral suppression at 12 months, defined as the proportion of all participants with a VL \<20 copies/mL
12-months viral suppression (<400copies/mL) 12 months (range: 10 - 15 months) after enrolment. Viral suppression at 12 months, defined as the proportion of all participants with a VL \<400 copies/mL
- Secondary Outcome Measures
Name Time Method Unconfirmed transfer out at 12 months 12 months (range 10 - 15 months) after enrolment 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
Sustained viral suppression 12 months (range 5 - 15 months) after enrollment 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
Loss to follow-up at 12 months 12 months (range 10 - 15 months) after enrollment The proportion of all participants lost to follow-up
Confirmed transfer out at 12 months 12 months (range 10 - 15 months) after enrolment 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)
Alternative viral suppression at 6 months 6 months (range 5 - 8 months) after enrolment The proportion of all participants with a VL \<1000 copies/mL
3-months linkage to care 90 days 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
12-months retention in care 12 months (range 10 - 15 months) after enrolment the proportion of all participants active in care at a health facility or at the VHW
All-cause mortality at 12 months 12 months (range 10 - 15 months) after enrolment The proportion of all participants who died
1-month linkage to care 30 days after enrollment 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
6-months viral suppression 6 months (range 5 - 8 months) after enrolment Viral suppression at 6 months, defined as the proportion of all participants with a VL \<20 copies/mL
Alternative viral suppression at 12 months 12 months (range 10 - 15 months) after enrolment. The proportion of all participants with a VL \<1000 copies/mL
6-months retention in care 5-8 months after enrollment The proportion of all participants active in care at a health facility or at the VHW 6 months (range 5 - 8 months) after enrollment
Trial Locations
- Locations (2)
District of Butha-Buthe
🇱🇸Butha-Buthe, Lesotho
District of Mokhotlong
🇱🇸Mokhotlong, Lesotho