Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Public Health
Published in: BMC Public Health 1/2016

Open Access 01-12-2016 | Study protocol

Same day 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 (CASCADE trial)

Authors: Niklaus Daniel Labhardt, Isaac Ringera, Thabo Ishmael Lejone, Phofu Masethothi, T’sepang Thaanyane, Mashaete Kamele, Ravi Shankar Gupta, Kyaw Thin, Bernard Cerutti, Thomas Klimkait, Christiane Fritz, Tracy Renée Glass

Published in: BMC Public Health | Issue 1/2016

Login to get access

Abstract

Background

Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation.

Methods

This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms.

Discussion

This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings.

Trial registration

NCT02692027, registered February 21, 2016
Literature
1.
90-90-90 An ambitious treatment target to help end the AIDS epidemic. UNAIDS/JC2684 (accessed 30th October 2014 at www.​unaids.​org) 2014.
2.
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JHS, 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;365:493–505.
3.
Fogel JM, Hudelson SE, Ou SS, Hart S, Wallis C, Morgado MG, Saravanan S, Tripathy S, Hovind L, Piwowar-Manning E, Sabin D, McCauley M, Gamble T, Zhang XC, Eron JJ, Gallant JE, Kumwenda J, Makhema J, Kumarasamy N, Chariyalertsak S, Hakim J, Badal-Faesen S, Akelo V, Hosseinipour MC, Santos BR, Godbole SV, Pilotto JH, Grinsztejn B, Panchia R, Mayer KH, Chen YQ, Cohen MS, Eshleman SH: HIV drug resistance in adults failing early antiretroviral treatment: results from the HIV Prevention Trials Network 052 trial. J Acquir Immune Defic Syndr; 2016. [Epub ahead of print].
4.
Jones 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 2014.384:272–79.CrossRefPubMed
5.
TEMPRANO ANRS 12136 Study Group. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med 2015;373:808–822.
6.
INSIGHT START Study Group. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015;373:795–807.CrossRef
7.
8.
9.
Delva W, Abdool Karim Q. The HIV epidemic in Southern Africa - Is an AIDS-free generation possible? Curr HIV/AIDS Rep. 2014;11:99–108.CrossRefPubMed
10.
MacCarthy 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;18:19395.
11.
Yehia 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;10:e0129376.
12.
Piñeirúa A, Sierra-Madero J, Cahn P, Guevara Palmero RN, Martínez Buitrago E, Young B, Del Rio C. The HIV care continuum in Latin America: challenges and opportunities. Lancet Infect Dis. 2015;15:833–9.CrossRefPubMed
13.
Kranzer 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;15:17383.CrossRefPubMedPubMedCentral
14.
15.
Piot P, Abdool Karim SS, Hecht R, Legido-Quigley H, Buse K, Stover J, Resch S, Ryckman T, Møgedal S, Dybul M, Goosby E, Watts C, Kilonzo N, McManus J, Sidibé M, UNAIDS–Lancet Commission. Defeating AIDS-advancing global health. Lancet 2015.
16.
Nachega 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;59 Suppl 1:S21–7.CrossRefPubMedPubMedCentral
17.
Naik 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;18:19843.
18.
Parker LA, Jobanputra K, Rusike L, Mazibuko S, Okello V, Kerschberger B, Jouquet G, Cyr J, Teck R. Feasibility and effectiveness of two community based HIV testing models in rural Swaziland. Trop Med Int Health. 2015;20:893–902.CrossRefPubMedPubMedCentral
19.
Clouse K, Pettifor AE, Maskew M, Bassett J, Van Rie A, Behets F, Gay C, Sanne I, Fox MP. Patient retention from HIV diagnosis through one year on antiretroviral therapy at a primary health care clinic in Johannesburg, South Africa. J Acquir Immune Defic Syndr. 2013;62:e39–46.
20.
Gerdts SE, Wagenaar BH, Micek MA, Farquhar C, Kariaganis M, Amos J, Gimbel S, Pfeiffer J, Gloyd S, Sherr K. Linkage to HIV Care and Antiretroviral Therapy by HIV Testing Service Type in Central Mozambique: A Retrospective Cohort Study. J Acquir Immune Defic Syndr 2013;66:e37–e44.
21.
Bassett I, Regan S, Luthuli P, Mbonambi H, Bearnot B, Pendleton A, Robine M, Mukuvisi D, Thulare H, Walensky R, Freedberg K, Losina E, Mhlongo B: Linkage to care following community-based mobile HIV testing compared with clinic-based testing in Umlazi Township, Durban, South Africa. HIV Med. 2013;15:367–372.PubMed
22.
Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-Based Versus Mobile Clinic HIV Testing and Counseling in Rural Lesotho: A Cluster-Randomized Trial. PLoS Med. 2014;11:e1001768.
23.
Wynberg E, Cooke G, Shroufi A, Reid SD, Ford N. Impact of point-of-care CD4 testing on linkage to HIV care: a systematic review. J Int AIDS Soc. 2014;17:18809.CrossRefPubMedPubMedCentral
24.
Kohler PK, Chung MH, McGrath CJ, Benki-Nugent SF, Thiga JW, John-Stewart GC. Implementation of free cotrimoxazole prophylaxis improves clinic retention among antiretroviral therapy-ineligible clients in Kenya. AIDS. 2011;25:1657–61.CrossRefPubMedPubMedCentral
25.
Cantrell RA, Sinkala M, Megazinni K, Lawson-Marriott S, Washington S, Chi BH, Tambatamba-Chapula B, Levy J, Stringer EM, Mulenga L, Stringer JSA. A pilot study of food supplementation to improve adherence to antiretroviral therapy among food-insecure adults in Lusaka, Zambia. J Acquir Immune Defic Syndr. 2008;49:190–5.
26.
Muhamadi L, Tumwesigye NM, Kadobera D, Marrone G, Wabwire-Mangen F, Pariyo G, Peterson S, Ekström AM. A single-blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in Eastern Uganda. Trials. 2011;12:184.
27.
Franke MF, Kaigamba F, Socci AR, Hakizamungu M, Patel A, Bagiruwigize E, Niyigena P, Walker KDC, Epino H, Binagwaho A, Mukherjee J, Farmer PE, Rich ML. Improved retention associated with community-based accompaniment for antiretroviral therapy delivery in rural Rwanda. Clin Infect Dis. 2013;56:1319–26.
28.
Hatcher AM, Turan JM, Leslie HH, Kanya LW, Kwena Z, Johnson MO, Shade SB, Bukusi EA, Doyen A, Cohen CR. Predictors of linkage to care following community-based HIV counseling and testing in rural Kenya. AIDS Behav. 2012;16:1295–307.
29.
Okeke NL, Ostermann J, Thielman NM. Enhancing linkage and retention in HIV care: a review of interventions for highly resourced and resource-poor settings. Curr HIV/AIDS Rep. 2014;11:376–92.CrossRefPubMed
30.
Govindasamy D, Meghij J, Kebede Negussi E, Clare Baggaley R, Ford N, Kranzer K. Interventions to improve or facilitate linkage to or retention in pre-ART (HIV) care and initiation of ART in low- and middle-income settings--a systematic review. J Int AIDS Soc. 2014;17:19032.CrossRefPubMedPubMedCentral
31.
Posse M, Baltussen R. Costs of providing food assistance to HIV/AIDS patients in Sofala province, Mozambique: a retrospective analysis. Cost Eff Resour Alloc. 2013;11:20.CrossRefPubMedPubMedCentral
32.
Govindasamy D, Ford N, Kranzer K. Risk factors, barriers and facilitators for linkage to antiretroviral therapy care: a systematic review. AIDS. 2012;26:2059–67.CrossRefPubMed
33.
Williams BG, Gouws E, Somse P, Mmelesi M, Lwamba C, Chikoko T, Fazito E, Turay M, Kiwango E, Chikukwa P, Damisoni H, Gboun M. Epidemiological Trends for HIV in Southern Africa: Implications for Reaching the Elimination Targets. Curr HIV/AIDS Rep. 2015;12:196–206.
34.
35.
Ministry of Health and Social Welfare Lesotho. National Guidelines For HIV Testing And Counselling, National Guidelines For HIV Testing And Counselling. 2009.
36.
Ministry of Health of Lesotho. National guidelines on the use of antiretroviral therapy for HIV prevention and treatment, National guidelines on the use of antiretroviral therapy for HIV prevention and treatment. 2013.
37.
World Health Organization: Consolidated Guidelines on the Use of antiretroviral Drugs for treating and preventing HIV Infection. available at: www.​who.​int, 2013. Accessed 15 May 2015.
38.
Smith JA, Sharma M, Levin C, Baeten JM, van Rooyen H, Celum C, Hallett TB, Barnabas RV. Cost-effectiveness of community-based strategies to strengthen the continuum of HIV care in rural South Africa: a health economic modelling analysis. Lancet HIV. 2015;2:e159–68.
39.
Genberg BL, Naanyu V, Wachira J, Hogan JW, Sang E, Nyambura M, Odawa M, Duefield C, Ndege S, Braitstein P. Linkage to and engagement in HIV care in western Kenya: An observational study using population-based estimates from home-based counseling and testing. Lancet HIV. 2015;2:e20–6.
40.
Ferrand R, Ford N, Kranzer K. Maximising the benefits of home-based HIV testing. Lancet HIV. 2015;2:e4–5.CrossRefPubMed
41.
Metadata
Title
Same day 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 (CASCADE trial)
Authors
Niklaus Daniel Labhardt
Isaac Ringera
Thabo Ishmael Lejone
Phofu Masethothi
T’sepang Thaanyane
Mashaete Kamele
Ravi Shankar Gupta
Kyaw Thin
Bernard Cerutti
Thomas Klimkait
Christiane Fritz
Tracy Renée Glass
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2016
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-016-2972-6

Other articles of this Issue 1/2016

BMC Public Health 1/2016 Go to the issue

Research article

Utilisation of health services and the poor: deconstructing wealth-based differences in facility-based delivery in the Philippines

Hypothesis

The Chinese-born immigrant infant feeding and growth hypothesis

Research article

Trends in major risk factors and mortality from main non-communicable diseases in Lithuania, 1985–2013

Research article

The art of being mentally healthy: a study to quantify the relationship between recreational arts engagement and mental well-being in the general population

Research article

Detecting and staging podoconiosis cases in North West Cameroon: positive predictive value of clinical screening of patients by community health workers and researchers

Research article

The effects of maximising the UK’s tobacco control score on inequalities in smoking prevalence and premature coronary heart disease mortality: a modelling study