Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, Lesotho | OTHER_GOV |
| SolidarMed | OTHER |
| University of Basel | OTHER |
| University Hospital, Basel, Switzerland |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator |
|
|
| Village-based ART refill | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Clinic-based HIV care |
| |
| Village-based ART refill |
| 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. |
| 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 |
Not provided
Inclusion Criteria for clusters:
Exclusion criteria for clusters:
Inclusion Criteria for individuals:
Exclusion criteria individuals:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niklaus D Labhardt, MD | University Hospital Basel & Swiss Tropical and Public Health Institute | Principal Investigator |
| Tracy R Glass, PhD | Swiss Tropical & Public Health Institute | Study Chair |
| Manuel Battegay, MD | University Hospital, Basel, Switzerland | Study Chair |
| Josephine Muhairwe, MD | SolidarMed - Swiss Organization for Health in Africa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| District of Butha-Buthe | Butha-Buthe | Lesotho | ||||
| District of Mokhotlong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34673765 | Derived | Amstutz A, Lejone TI, Khesa L, Kopo M, Kao M, Muhairwe J, Bresser M, Raber F, Klimkait T, Battegay M, Glass TR, Labhardt ND. Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial. PLoS Med. 2021 Oct 21;18(10):e1003839. doi: 10.1371/journal.pmed.1003839. eCollection 2021 Oct. | |
| 31439004 |
| Label | URL |
|---|---|
| Official Project Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol V6 approved by Ethics Board on May 30, 2018 | Apr 20, 2018 | Dec 18, 2018 | Prot_SAP_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Amended Protocol V7 approved by Ethics Board on Oct 9, 2018 | Sep 25, 2018 | Dec 18, 2018 | Prot_SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| OTHER |
Parallel cluster-randomized
Not provided
Not provided
Not provided
Not provided
| Other |
Option to get ART refill and care by the village health worker |
|
|
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 |
| Mokhotlong |
| Lesotho |
| Derived |
| Amstutz A, Lejone TI, Khesa L, Muhairwe J, Nsakala BL, Tlali K, Bresser M, Tediosi F, Kopo M, Kao M, Klimkait T, Battegay M, Glass TR, Labhardt ND. VIBRA trial - Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho. Trials. 2019 Aug 22;20(1):522. doi: 10.1186/s13063-019-3510-5. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |