A Phase 4 interventional study of Standard of Care and Village-based ART refill in HIV/AIDS, sponsored by Niklaus Labhardt. Completed at 2 sites in Lesotho. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Niklaus Labhardt · Phase 4, Interventional, and Health services research
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.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 257 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Niklaus Labhardt is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for clusters:
Exclusion criteria for clusters:
Inclusion Criteria for individuals:
Exclusion criteria individuals:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Standard of Care
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
Other: Village-based ART refill
Clinic-based HIV care
Option to get ART refill and care by the village health worker
Also known as: VIBRA
12-months viral suppression
Viral suppression at 12 months, defined as the proportion of all participants with a VL \<20 copies/mL
Time frame: 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
Time frame: 12 months (range: 10 - 15 months) after enrolment.
6-months viral suppression
Viral suppression at 6 months, defined as the proportion of all participants with a VL \<20 copies/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months (range 10 - 15 months) after enrolment
All-cause mortality at 12 months
The proportion of all participants who died
Time frame: 12 months (range 10 - 15 months) after enrolment
Loss to follow-up at 12 months
The proportion of all participants lost to follow-up
Time frame: 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)
Time frame: 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
Time frame: 12 months (range 10 - 15 months) after enrolment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2018 to primary completion in Dec 2020, 27 months.
Of 64 non-industry phase 4 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 49. This study's 27 months is below that.
Counting every sponsor, half of 70 studies reached it within 31 months; a quarter within 22 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Niklaus Labhardt