HIV InfectionPhase 3CASCADENCT02692027
Same-day ART Initiation Versus Standard of Care After Positive HIV-test Result in Rural Lesotho
A Phase 3 study testing Same-day ART initiation in people with HIV Infection, run by Swiss Tropical & Public Health Institute at 1 site in Lesotho.
Trial summary
The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Same-day ART initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteLesotho
- Study dates
- Feb 2016to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection newly diagnosed during community-based HTC-campaigns
- Never been on triple-ART
- Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the 6 health facilities involved in the study
- Signed written informed consent
Who cannot join
- Pregnant or breast-feeding
- Already enrolled in chronic care for another disease, such as tuberculosis or diabetes
- Clinical WHO-stage 4 or active tuberculosis
- Positive cryptococcal antigen test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Same Day Community-based ART Initiation Versus Clinic-based Pre-ART Assessment and Counselling for Individuals Newly Tested HIV-positive During Community-based HIV Testing in Rural Lesotho - a Randomized Controlled Trial
The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment.
Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.
Read the detailed description
A published version of the trial protocol can be downloaded at:
http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-2972-6
Background
In November 2014 the Joint United Nations Programme on HIV/AIDS (UNAIDS) published the 90-90-90 targets for 2020 (UNAIDS 2014). The strategy aims at a massive scale-up in coverage of antiretroviral therapy (ART) among individuals infected with HIV. Based on accumulated evidence that viral suppression through successful ART reduces the risk of transmission(Cohen 2011), it is expected that - if achieved - the 90-90-90 targets would lead to a reduction of the yearly global HIV-incidence from 2 million currently to 500'000 by 2020 (Jones 2014). In 2015 two randomized controlled trials showed the benefit of starting ART as early as possible for infected individuals - even if CD4-cell counts were above the threshold of 500 cells/mL (TEMPRANO 2015; INSIGHT START 2015), leading the World Health Organization (WHO) to recommend that anyone infected with HIV should start ART as soon as possible after diagnosis (WHO 2015). A "seek-test-treat" strategy bears, however, unprecedented challenges in settings where HIV is hyperendemic and resources may be limited (Hull 2014; Delva 2015).
The Continuum of Care Cascade ("the cascade") involves the steps HIV-infected individuals have to take in order to achieve viral suppression. It starts with knowing one's HIV status, continues with linkage to care after a positive HIV test, initiation of ART, uninterrupted continuation of ART (retention in care and adherence to medication), and ends with viral suppression (MacCarthy 2015). Already prior to announcement of the "seek-test-and-treat" approach, weaknesses in the cascade often hampered the effectiveness of HIV programs in resource-rich as well as resource-poor settings (Yehia 2015; Kratzer 2012). In Sub-Saharan Africa the care cascade is still far from the 90-90-90 targets with only 29% of infected individuals estimated to be on ART and virally suppressed in 2013. In order to achieve the UNAIDS targets innovative, effective, and practical approaches for improving the care cascade are thus urgently needed (Mills 2013; Piot 2015).
Linkage to care after an initial positive HIV test has been described as the "Achilles' heel" of the care cascade (Nachega 2014). Most studies from Sub-Saharan Africa report linkage rates lower than 50% (Naik 2015; Parker 2015; Clouse 2013; Gerdts 2014). In a cluster-randomized trial comparing home-based with mobile-clinic HIV testing and counselling (HTC) in Lesotho, only 25% of newly tested HIV-positive individuals accessed care within one month after the test (Labhardt 2014).
Several interventions have been shown to improve linkage to care, such as point-of-care CD4 count directly after a positive HIV test, immediate start of cotrimoxazole prophylaxis, incentives such as food-assistance, extended post-test counselling during home-visits, or community-workers accompaniment. However, controlled studies testing programmatic intervention packages for improving linkage to care are still largely lacking (Okeke 2014; Govindasamy 2014). Furthermore, it must be noted that interventions, such as patient-accompaniment or food support are resource intensive and may work in small NGO-driven projects, but are not sustainable on a larger scale (Posse 2013). In a systematic review addressing barriers for linkage to care, transport cost and distance were the most frequently cited factors for patients not enrolling in care after a positive HIV test (Govindasamy 2012).
Objective of the trial
This CASCADE trial tests the effectiveness of same day home-based ART initiation after a positive HIV test in combination with a reduction of the frequency of follow-up visits to the clinic as a pragmatic and programmatically feasible approach to improve linkage to care, retention in care, and viral suppression.
It is a two-armed open-label randomized controlled trial. Allocation is 1:1 with parallel assignment. The intervention is targeted to individuals who tested HIV-positive during community-based HTC.
Recruitment and participants
Participants will be recruited during community-based HTC campaigns in the district of Butha-Buthe, in northern Lesotho. Home-based HTC campaigns will be conducted for an anticipated period of 3 months beginning at the end of February in the catchment areas of six health care facilities - four nurse-led health centers, one missionary and one public hospital.
Three teams consisting of 4 lay counsellors, each supervised by one professional counsellor and a nurse visit all households in randomly pre-selected areas proposing HTC to all household members. If a household member tests HIV positive during the HTC campaign and eligible for the CASCADE trial, he/she will be randomized to one of the two arms.
- Conditions
- HIV Infection
- Being tested
- Same-day ART initiation, Standard of care
- Keywords
- Community-based initiation of antiretroviral therapy, Home-based HIV testing and counseling, Lesotho, Sub-sahara Africa, antiretroviral therapy, AIDS, Test and treat
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day ART initiationOther
Participants tested HIV-positive during community-based HIV testing and randomized to the intervention group receive post-test counseling and on-the-spot clinical and laboratory assessment. Directly after the positive HIV-test result the study nurse assesses the participant clinically and performs point-of-care laboratory baseline testing. Thereafter, the participant receives a standardized short adherence counselling. After adherence counseling the participant is offered to start ART immediately. Those who decide to start ART during the visit or intend to start within seven days will receive a 30 day ART-supply and an follow-up appointment at the clinic within 12 to 16 days.
In order to reduce travel time and transport cost, participants who are clinically stable, will have their follow-up visits and ART refills more widely spaced with appointments at 6 weeks, 3, 6, (9) and 12 months after ART initiation.
Standard of careOther
Individuals found HIV-positive during the community-based HIV testing campaigns and randomized to the control arm receive post-test counselling and a referral letter with an appointment at their chosen health facility. On the first visit to the clinic, the participant receives laboratory assessment and a first adherence counselling session. The participant must then return to the clinic to receive his/her laboratory results and to undergo a second adherence counselling session.
Once the participant has started ART, the first and second follow-up visits are scheduled for 14 and 28 days after ART initiation, respectively. Thereafter, follow-up visits are scheduled monthly until 6 months after ART initiation. If the participant is clinically stable, clinical follow-up visits may then be spaced to 3-monthly intervals, but refills of ART must still be collected on a monthly basis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard of care in Lesotho. ART-initiation after at least two clinic visits for pre-ART counseling and monthly follow-up visits at the clinic thereafter. Receives: Other: Standard of care |
| Same-day ART initiation with less frequent follow-up visits | Experimental | Proposition of same-day ART initiation with less frequent follow-up visits thereafter. Receives: Other: Same-day ART initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to care
Linkage to care within 3 months after having been tested HIV positive during the HTC-campaign. A patient is considered to have linked to care if he/she attends the clinic at least once within 90 days after HIV diagnosis.
Measured: 90 days
Viral suppression
Viral suppression 12 months after positive HIV test result. Viral suppression is defined as a viral load <100 copies/mL between 11 and 14 months after diagnosis of HIV-infection.
Measured: 12 months
Secondary outcomes (6)
1-year retention in care
Proportion confirmed dead (death record at clinic or confirmed by a first-grade relative), lost to follow-up (not attending the clinic 11-14 months after HIV-test and not confirmed dead), and retained in care (on ART, attends the clinic)
Measured: 12 months
Viral suppression under ART
Viral load <100 copies/mL among those who started ART 5-7 months after ART-initiation.
Measured: 6 months after ART initiation
Change in body weight
Measured: 12 months
Change in CD4 cell count
Measured: 12 months
Change in haemoglobin
Measured: 12 months
New clinical WHO stage 3 or 4 events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed - Swiss Organization for Health in Africa, Ministry of Health, Lesotho, District Health Management Team of Butha-Buthe, Lesotho, University of Basel, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Niklaus Labhardt, Swiss Tropical & Public Health Institute
- Investigators
- Niklaus D Labhardt, MD, MIH, Principal investigator, Swiss Tropical & Public Health InstituteTracy R Glass, PhD, Study chair, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692027
- Sponsor's protocol ID
- CASCADE
- Acronym
- CASCADE
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
90-90-90 An ambitious treatment target to help end the AIDS epidemic. UNAIDS / JC2684 (accessed October 30th 2014 at www.unaids.org) 2014.
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
PubMed 21767103TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
PubMed 26193126INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.
PubMed 26192873Jones A, Cremin I, Abdullah F, Idoko J, Cherutich P, Kilonzo N, Rees H, Hallett T, O'Reilly K, Koechlin F, Schwartlander B, de Zalduondo B, Kim S, Jay J, Huh J, Piot P, Dybul M. Transformation of HIV from pandemic to low-endemic levels: a public health approach to combination prevention. Lancet. 2014 Jul 19;384(9939):272-9. doi: 10.1016/S0140-6736(13)62230-8. Epub 2014 Apr 14.
PubMed 24740087Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
PubMed 26598776Hull M, Lange J, Montaner JS. Treatment as prevention--where next? Curr HIV/AIDS Rep. 2014 Dec;11(4):496-504. doi: 10.1007/s11904-014-0237-5.
PubMed 25384357Delva W, Abdool Karim Q. The HIV epidemic in Southern Africa - Is an AIDS-free generation possible? Curr HIV/AIDS Rep. 2014 Jun;11(2):99-108. doi: 10.1007/s11904-014-0205-0.
PubMed 24676559MacCarthy S, Hoffmann M, Ferguson L, Nunn A, Irvin R, Bangsberg D, Gruskin S, Dourado I. The HIV care cascade: models, measures and moving forward. J Int AIDS Soc. 2015 Mar 2;18(1):19395. doi: 10.7448/IAS.18.1.19395. eCollection 2015.
PubMed 25735869Yehia BR, Stephens-Shields AJ, Fleishman JA, Berry SA, Agwu AL, Metlay JP, Moore RD, Christopher Mathews W, Nijhawan A, Rutstein R, Gaur AH, Gebo KA; HIV Research Network. The HIV Care Continuum: Changes over Time in Retention in Care and Viral Suppression. PLoS One. 2015 Jun 18;10(6):e0129376. doi: 10.1371/journal.pone.0129376. eCollection 2015.
PubMed 26086089Kranzer K, Govindasamy D, Ford N, Johnston V, Lawn SD. Quantifying and addressing losses along the continuum of care for people living with HIV infection in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2012 Nov 19;15(2):17383. doi: 10.7448/IAS.15.2.17383.
PubMed 23199799Mills EJ, Nachega JB, Ford N. Can we stop AIDS with antiretroviral-based treatment as prevention? Glob Health Sci Pract. 2013 Mar 21;1(1):29-34. doi: 10.9745/GHSP-D-12-00053. eCollection 2013 Mar.
PubMed 25276515Piot P, Abdool Karim SS, Hecht R, Legido-Quigley H, Buse K, Stover J, Resch S, Ryckman T, Mogedal S, Dybul M, Goosby E, Watts C, Kilonzo N, McManus J, Sidibe M; UNAIDS-Lancet Commission. Defeating AIDS--advancing global health. Lancet. 2015 Jul 11;386(9989):171-218. doi: 10.1016/S0140-6736(15)60658-4. Epub 2015 Jun 24. No abstract available.
PubMed 26117719Nachega JB, Uthman OA, del Rio C, Mugavero MJ, Rees H, Mills EJ. Addressing the Achilles' heel in the HIV care continuum for the success of a test-and-treat strategy to achieve an AIDS-free generation. Clin Infect Dis. 2014 Jul;59 Suppl 1(Suppl 1):S21-7. doi: 10.1093/cid/ciu299.
PubMed 24926028Naik R, Doherty T, Jackson D, Tabana H, Swanevelder S, Thea DM, Feeley FG, Fox MP. Linkage to care following a home-based HIV counselling and testing intervention in rural South Africa. J Int AIDS Soc. 2015 Jun 8;18(1):19843. doi: 10.7448/IAS.18.1.19843. eCollection 2015.
PubMed 26058983
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Community-based ART Initiation Versus Clinic-based Pre-ART Assessment and Counselling for Individuals Newly Tested HIV-positive During Community-based HIV Testing in Rural Lesotho - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02692027
- Acronym / sponsor ID
- CASCADE / CASCADE
- Conditions
- HIV Infection
- Keywords
- Community-based initiation of antiretroviral therapy, Home-based HIV testing and counseling, Lesotho, Sub-sahara Africa, antiretroviral therapy, AIDS, Test and treat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- SolidarMed - Swiss Organization for Health in Africa, Ministry of Health, Lesotho, District Health Management Team of Butha-Buthe, Lesotho, University of Basel, University of Geneva, Switzerland
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment.
Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.
Detailed description
A published version of the trial protocol can be downloaded at:
http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-2972-6
Background
In November 2014 the Joint United Nations Programme on HIV/AIDS (UNAIDS) published the 90-90-90 targets for 2020 (UNAIDS 2014). The strategy aims at a massive scale-up in coverage of antiretroviral therapy (ART) among individuals infected with HIV. Based on accumulated evidence that viral suppression through successful ART reduces the risk of transmission(Cohen 2011), it is expected that - if achieved - the 90-90-90 targets would lead to a reduction of the yearly global HIV-incidence from 2 million currently to 500'000 by 2020 (Jones 2014). In 2015 two randomized controlled trials showed the benefit of starting ART as early as possible for infected individuals - even if CD4-cell counts were above the threshold of 500 cells/mL (TEMPRANO 2015; INSIGHT START 2015), leading the World Health Organization (WHO) to recommend that anyone infected with HIV should start ART as soon as possible after diagnosis (WHO 2015). A "seek-test-treat" strategy bears, however, unprecedented challenges in settings where HIV is hyperendemic and resources may be limited (Hull 2014; Delva 2015).
The Continuum of Care Cascade ("the cascade") involves the steps HIV-infected individuals have to take in order to achieve viral suppression. It starts with knowing one's HIV status, continues with linkage to care after a positive HIV test, initiation of ART, uninterrupted continuation of ART (retention in care and adherence to medication), and ends with viral suppression (MacCarthy 2015). Already prior to announcement of the "seek-test-and-treat" approach, weaknesses in the cascade often hampered the effectiveness of HIV programs in resource-rich as well as resource-poor settings (Yehia 2015; Kratzer 2012). In Sub-Saharan Africa the care cascade is still far from the 90-90-90 targets with only 29% of infected individuals estimated to be on ART and virally suppressed in 2013. In order to achieve the UNAIDS targets innovative, effective, and practical approaches for improving the care cascade are thus urgently needed (Mills 2013; Piot 2015).
Linkage to care after an initial positive HIV test has been described as the "Achilles' heel" of the care cascade (Nachega 2014). Most studies from Sub-Saharan Africa report linkage rates lower than 50% (Naik 2015; Parker 2015; Clouse 2013; Gerdts 2014). In a cluster-randomized trial comparing home-based with mobile-clinic HIV testing and counselling (HTC) in Lesotho, only 25% of newly tested HIV-positive individuals accessed care within one month after the test (Labhardt 2014).
Several interventions have been shown to improve linkage to care, such as point-of-care CD4 count directly after a positive HIV test, immediate start of cotrimoxazole prophylaxis, incentives such as food-assistance, extended post-test counselling during home-visits, or community-workers accompaniment. However, controlled studies testing programmatic intervention packages for improving linkage to care are still largely lacking (Okeke 2014; Govindasamy 2014). Furthermore, it must be noted that interventions, such as patient-accompaniment or food support are resource intensive and may work in small NGO-driven projects, but are not sustainable on a larger scale (Posse 2013). In a systematic review addressing barriers for linkage to care, transport cost and distance were the most frequently cited factors for patients not enrolling in care after a positive HIV test (Govindasamy 2012).
Objective of the trial
This CASCADE trial tests the effectiveness of same day home-based ART initiation after a positive HIV test in combination with a reduction of the frequency of follow-up visits to the clinic as a pragmatic and programmatically feasible approach to improve linkage to care, retention in care, and viral suppression.
It is a two-armed open-label randomized controlled trial. Allocation is 1:1 with parallel assignment. The intervention is targeted to individuals who tested HIV-positive during community-based HTC.
Recruitment and participants
Participants will be recruited during community-based HTC campaigns in the district of Butha-Buthe, in northern Lesotho. Home-based HTC campaigns will be conducted for an anticipated period of 3 months beginning at the end of February in the catchment areas of six health care facilities - four nurse-led health centers, one missionary and one public hospital.
Three teams consisting of 4 lay counsellors, each supervised by one professional counsellor and a nurse visit all households in randomly pre-selected areas proposing HTC to all household members. If a household member tests HIV positive during the HTC campaign and eligible for the CASCADE trial, he/she will be randomized to one of the two arms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careStandard of care in Lesotho. ART-initiation after at least two clinic visits for pre-ART counseling and monthly follow-up visits at the clinic thereafter. |
| Same-day ART initiation with less frequent follow-up visits | Experimental | Other: Same-day ART initiationProposition of same-day ART initiation with less frequent follow-up visits thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection newly diagnosed during community-based HTC-campaigns
- Never been on triple-ART
- Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the 6 health facilities involved in the study
- Signed written informed consent
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding
- Already enrolled in chronic care for another disease, such as tuberculosis or diabetes
- Clinical WHO-stage 4 or active tuberculosis
- Positive cryptococcal antigen test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-day ART initiationParticipants tested HIV-positive during community-based HIV testing and randomized to the intervention group receive post-test counseling and on-the-spot clinical and laboratory assessment. Directly after the positive HIV-test result the study nurse assesses the participant clinically and performs point-of-care laboratory baseline testing. Thereafter, the participant receives a standardized short adherence counselling. After adherence counseling the participant is offered to start ART immediately. Those who decide to start ART during the visit or intend to start within seven days will receive a 30 day ART-supply and an follow-up appointment at the clinic within 12 to 16 days. In order to reduce travel time and transport cost, participants who are clinically stable, will have their follow-up visits and ART refills more widely spaced with appointments at 6 weeks, 3, 6, (9) and 12 months after ART initiation. | Other | Same-day ART initiation with less frequent follow-up visits |
| Standard of careIndividuals found HIV-positive during the community-based HIV testing campaigns and randomized to the control arm receive post-test counselling and a referral letter with an appointment at their chosen health facility. On the first visit to the clinic, the participant receives laboratory assessment and a first adherence counselling session. The participant must then return to the clinic to receive his/her laboratory results and to undergo a second adherence counselling session. Once the participant has started ART, the first and second follow-up visits are scheduled for 14 and 28 days after ART initiation, respectively. Thereafter, follow-up visits are scheduled monthly until 6 months after ART initiation. If the participant is clinically stable, clinical follow-up visits may then be spaced to 3-monthly intervals, but refills of ART must still be collected on a monthly basis. | Other | Standard of care |
Primary outcome
Linkage to care
Time frame: 90 days
Linkage to care within 3 months after having been tested HIV positive during the HTC-campaign. A patient is considered to have linked to care if he/she attends the clinic at least once within 90 days after HIV diagnosis.
Viral suppression
Time frame: 12 months
Viral suppression 12 months after positive HIV test result. Viral suppression is defined as a viral load <100 copies/mL between 11 and 14 months after diagnosis of HIV-infection.
6 secondary outcomes
1-year retention in care
Time frame: 12 months
Viral suppression under ART
Time frame: 6 months after ART initiation
Change in body weight
Time frame: 12 months
Change in CD4 cell count
Time frame: 12 months
Change in haemoglobin
Time frame: 12 months
New clinical WHO stage 3 or 4 events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background90-90-90 An ambitious treatment target to help end the AIDS epidemic. UNAIDS / JC2684 (accessed October 30th 2014 at www.unaids.org) 2014.
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- Background: PubMed 26193126TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklaus D Labhardt, MD, MIH principal investigator
Swiss Tropical & Public Health Institute
Tracy R Glass, PhD study chair
Swiss Tropical & Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Same-day ART initiation in people with HIV Infection, run by Swiss Tropical & Public Health Institute at 1 site in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to care (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692027, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.