HIV/AIDS
Conditions
Keywords
HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy
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.
Interventions
OTHERStandard of Care
Clinic-based HIV care
OTHERVillage-based ART refill
Option to get ART refill and care by the village health worker
Sponsors
Niklaus Labhardt
Ministry of Health, Lesotho
SolidarMed
University of Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel cluster-randomized
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| All-cause mortality at 12 months | 12 months (range 10 - 15 months) after enrolment | The proportion of all participants who died |
| 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) |
| 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 |
| 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 |
| 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 |
Countries
Lesotho
Outcome results
None listed