Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal

Joanna Orne-Gliemann, Joseph Larmarange, Sylvie Boyer, Collins Iwuji, Nuala McGrath, Till Bärnighausen, Thembelile Zuma, Rosemary Dray-Spira, Bruno Spire, Tamsen Rochat, France Lert, John Imrie, ANRS 12249 TasP Group, François Dabis, Marie-Louise Newell, Deenan Pillay, Collins Iwuji, Joanna Orne-Gliemann, Till Bärnighausen, Eric Balestre, Sylvie Boyer, Alexandra Calmy, Vincent Calvez, Marie-Laure Chaix, Rosemary Dray-Spira, Kamal ElFarouki, Kenneth Freedberg, Kobus Herbst, John Imrie, Sophie Karcher, Joseph Larmarange, France Lert, Richard Lessells, Thembisa Makowa, Anne-Geneviève Marcelin, Laura March, Nuala McGrath, Kevi Naidu, Colin Newell, Nonhlanhla Okesola, Tulio de Oliveira, Melanie Plazy, Tamsen Rochat, Bruno Spire, Frank Tanser, Rodolphe Thiébaut, Johannes Viljoen, Thembelile Zuma, Xavier Anglaret, Hoosen Cooavdia, Alpha Diallo, Bruno Giraudeau, Jean-Michel Molina, Lynn Morris, François Venter, Sibongile Zungu, Eric Fleutelot, Eric Goemaere, Calice Talom, Brigitte Bazin, Claire Rekacewicz, Golriz Pahlavan-Grumel, Alice Jacob, Patrick Yeni, Sinead Delany-Moretlwe, Nathan Ford, Catherine Hankins, Helen Weiss, Joanna Orne-Gliemann, Joseph Larmarange, Sylvie Boyer, Collins Iwuji, Nuala McGrath, Till Bärnighausen, Thembelile Zuma, Rosemary Dray-Spira, Bruno Spire, Tamsen Rochat, France Lert, John Imrie, ANRS 12249 TasP Group, François Dabis, Marie-Louise Newell, Deenan Pillay, Collins Iwuji, Joanna Orne-Gliemann, Till Bärnighausen, Eric Balestre, Sylvie Boyer, Alexandra Calmy, Vincent Calvez, Marie-Laure Chaix, Rosemary Dray-Spira, Kamal ElFarouki, Kenneth Freedberg, Kobus Herbst, John Imrie, Sophie Karcher, Joseph Larmarange, France Lert, Richard Lessells, Thembisa Makowa, Anne-Geneviève Marcelin, Laura March, Nuala McGrath, Kevi Naidu, Colin Newell, Nonhlanhla Okesola, Tulio de Oliveira, Melanie Plazy, Tamsen Rochat, Bruno Spire, Frank Tanser, Rodolphe Thiébaut, Johannes Viljoen, Thembelile Zuma, Xavier Anglaret, Hoosen Cooavdia, Alpha Diallo, Bruno Giraudeau, Jean-Michel Molina, Lynn Morris, François Venter, Sibongile Zungu, Eric Fleutelot, Eric Goemaere, Calice Talom, Brigitte Bazin, Claire Rekacewicz, Golriz Pahlavan-Grumel, Alice Jacob, Patrick Yeni, Sinead Delany-Moretlwe, Nathan Ford, Catherine Hankins, Helen Weiss

Abstract

Background: The Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies.

Methods/design: A social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods.

Discussion: The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at individual, community, patient and health system level, to complement the trial's clinical and epidemiological outcomes. It will also increase understanding of the causal impacts of UTT on social and economic outcomes, which will be critical for the long-term sustainability and routine UTT implementation.

Trial registration: Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.

Figures

Figure 1
Figure 1
Components of the ANRS 12249 TasP trial social research programme: surveys, populations and tools.

References

    1. AVAC . Antiretroviral treatment for prevention of HIV and tuberculosis: 2013 update on current and planned research efforts. New York: AVAC; 2014. p. 64.
    1. Iwuji CC, Orne-Gliemann J, Tanser F, Boyer S, Lessells RJ, Lert F, et al. Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial. Trials. 2013;14:230. doi: 10.1186/1745-6215-14-230.
    1. Impact of Immediate Versus WHO Recommendations Guided ART Initiation on HIV Incidence - Feasibility Phase (TasP) - NCT01509508. []
    1. Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) - NCT01900977. []
    1. Hayes R, Ayles H, Beyers N, Sabapathy K, Floyd S, Shanaube K, et al. HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment – a study protocol for a cluster randomised trial. Trials. 2014;15:57. doi: 10.1186/1745-6215-15-57.
    1. Sustainable East Africa Research in Community Health (SEARCH) - NCT01864603. [].
    1. Botswana Combination Prevention Project (BCPP) - NCT01965470. [].
    1. Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009;373:48–57. doi: 10.1016/S0140-6736(08)61697-9.
    1. Hontelez JAC, Lurie MN, Bärnighausen T, Bakker R, Baltussen R, Tanser F, et al. Elimination of HIV in South Africa through expanded access to antiretroviral therapy: a model comparison study. PLoS Med. 2013;10:e1001534. doi: 10.1371/journal.pmed.1001534.
    1. Eaton JW, Johnson LF, Salomon JA, Bärnighausen T, Bendavid E, Bershteyn A, et al. HIV Treatment as prevention: systematic comparison of mathematical models of the potential impact of antiretroviral therapy on HIV incidence in South Africa. PLoS Med. 2012;9:e1001245. doi: 10.1371/journal.pmed.1001245.
    1. Sabapathy K, Van den Bergh R, Fidler S, Hayes R, Ford N. Uptake of home-based voluntary HIV testing in Sub-Saharan Africa: a systematic review and meta-analysis. PLoS Med. 2012;9:e1001351. doi: 10.1371/journal.pmed.1001351.
    1. Obare F, Fleming P, Anglewicz P, Thornton R, Martinson F, Kapatuka A, et al. Acceptance of repeat population-based voluntary counselling and testing for HIV in rural Malawi. Sex Transm Infect. 2009;85:139–44. doi: 10.1136/sti.2008.030320.
    1. Helleringer S, Mkandawire J, Reniers G, Kalilani-Phiri L, Kohler HP. Should home-based HIV testing and counseling services be offered periodically in programs of ARV treatment as prevention? A Case Study in Likoma (Malawi) AIDS Behav. 2013;17(6):2100–8. doi: 10.1007/s10461-012-0365-0.
    1. Mugglin C, Estill J, Wandeler G, Bender N, Egger M, Gsponer T, et al. Loss to programme between HIV diagnosis and initiation of antiretroviral therapy in sub-Saharan Africa: systematic review and meta-analysis. Trop Med Int Health. 2012;17(12):1509–20. doi: 10.1111/j.1365-3156.2012.03089.x.
    1. World Health Organisation . Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a Public Health Approach. Geneva: WHO; 2013.
    1. Southern African HIV Clinicians Society . Statement on WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Johannesburg: SAHIVSOC; 2013.
    1. Bärnighausen T, Tanser F, Dabis F, Newell M-L. Interventions to improve the performance of HIV health systems for treatment-as-prevention in sub-Saharan Africa: the experimental evidence. Curr Opin HIV AIDS. 2012;7:140–50. doi: 10.1097/COH.0b013e32834fc1df.
    1. Zuma T, Newell M-L, Maphumulo K, Imrie J, Dabis F. Testing gives us a chance to get encouraged and say let us stand up…then we will get help’: Contrasting Community Representations of HIV Testing in the Context of Treatment as Prevention (Tasp) in Rural North-Eastern KwaZulu-Nata. Durban: 5th South Afr AIDS Conf; 2011.
    1. Zuma T, Maphumulo K, Newell M-L, Dabis F, Imrie J. Treatment as Prevention (TasP) Preparatory Study Report - Ukuphila Kwami, Ukuphila Kwethu - My Health for Our Health. Somkhele: Africa Centre for Health and Population Studies; 2012.
    1. Bond V, Hoddinott G, Simuyaba M, Abrahams K, Ayles H, Beyers N, et al. “What is this ‘Universal Test and Treat’ (UTT)?” Community understandings of key concepts linked to a combination HIV prevention strategy in 21 Zambian and South African communities. Melbourne: Oral communication n°WEAC0103 at 20th International AIDS Conference; 2014.
    1. Zaidi J, Grapsa E, Tanser F, Newell M-L, Bärnighausen T. Dramatic increase in HIV prevalence after scale-up of antiretroviral treatment. AIDS. 2013;27:2301–5. doi: 10.1097/QAD.0b013e328362e832.
    1. Iwuji C, Orne-Gliemann J, Tanser F, Thiébaut R, Larmarange J, Okesola N, et al. Feasibility and acceptability of an antiretroviral treatment as prevention (TasP) intervention in rural South Africa: results from the ANRS 12249 TasP cluster-randomised trial. Melbourne: Oral communication n°WEAC0105LB at 20th International AIDS Conference; 2014.
    1. Hull MW, Wu Z, Montaner JSG. Optimizing the engagement of care cascade: a critical step to maximize the impact of HIV treatment as prevention. Curr Opin HIV AIDS. 2012;7:579–86. doi: 10.1097/COH.0b013e3283590617.
    1. Coates TJ, Kulich M, Celentano DD, Zelaya CE, Chariyalertsak S, Chingono A, et al. Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health. 2014;2:e267–77. doi: 10.1016/S2214-109X(14)70032-4.
    1. Imrie J, Tanser F. Targeting strategies and behavior change to combat the HIV epidemic in southern Africa. Future Virol. 2011;6:793–800. doi: 10.2217/fvl.11.54.
    1. Van Rooyen H, Barnabas RV, Baeten JM, Phakathi Z, Joseph P, Krows M, et al. High HIV testing uptake and linkage to care in a novel program of home-based HIV counseling and testing with facilitated referral in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2013;64(1):e1–8. doi: 10.1097/QAI.0b013e31829b567d.
    1. 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. doi: 10.1097/QAD.0b013e3283578b9b.
    1. Anglaret X, Minga A, Gabillard D, Ouassa T, Messou E, Morris B, et al. AIDS and Non-AIDS morbidity and mortality across the spectrum of CD4 cell counts in HIV-infected adults before starting antiretroviral therapy in Côte d’Ivoire. Clin Infect Dis. 2012;54:714–23. doi: 10.1093/cid/cir898.
    1. Grinsztejn B, Hosseinipour MC, Ribaudo HJ, Swindells S, Eron J, Chen YQ, et al. Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis. 2014;14:281–90. doi: 10.1016/S1473-3099(13)70692-3.
    1. McGrath N, Eaton JW, Bärnighausen TW, Tanser F, Newell M-L. Sexual behaviour in a rural high HIV prevalence South African community: time trends in the antiretroviral treatment era. AIDS. 2013;27(15):2461–70. doi: 10.1097/01.aids.0000432473.69250.19.
    1. Jean K, Gabillard D, Moh R, Danel C, Fassassi R, Desgrées Du Loû A, et al. Effect of early antiretroviral therapy on sexual behaviors and HIV-1 transmission risk among adults with diverse heterosexual partnership statuses in Cote d’Ivoire. J Infect Dis. 2013;17:18977.
    1. McGrath N, Grapsa E, Newell M-L. Does ART contribute to behaviour change? : Partnership change and sexual behaviour among attenders of a public HIV treatment and care programme in rural KwaZulu-Natal, South Africa. Melbourne: 20th Int AIDS Conf; 2014.
    1. Bor J, Tanser F, Newell M-L, Bärnighausen T. In a study of a population cohort in South Africa, HIV patients on antiretrovirals had nearly full recovery of employment. Health Aff Proj Hope. 2012;31:1459–69. doi: 10.1377/hlthaff.2012.0407.
    1. Bärnighausen T, Salomon JA, Sangrujee N. HIV treatment as prevention: issues in economic evaluation. PLoS Med. 2012;9:e1001263. doi: 10.1371/journal.pmed.1001263.
    1. Rowe AK, de Savigny D, Lanata CF, Victora CG. How can we achieve and maintain high-quality performance of health workers in low-resource settings? Lancet. 2005;366:1026–35. doi: 10.1016/S0140-6736(05)67028-6.
    1. Tanser F, Hosegood V, Barnighausen T, Herbst K, Nyirenda M, Muhwava W, et al. Cohort Profile: Africa Centre Demographic Information System (ACDIS) and population-based HIV survey. Int J Epidemiol. 2008;37:956–62. doi: 10.1093/ije/dym211.
    1. Cleary S, Birch S, Chimbindi N, Silal S, McIntyre D. Investigating the affordability of key health services in South Africa. Soc Sci Med. 2013;80:37–46. doi: 10.1016/j.socscimed.2012.11.035.
    1. Rabin R, De CF. EQ-SD: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–43. doi: 10.3109/07853890109002087.
    1. EQ-5D-3L official language versions. []
    1. Chimbindi N, Bärnighausen T, Newell M-L. Patient satisfaction with HIV and TB treatment in a public programme in rural KwaZulu-Natal: evidence from patient-exit interviews. BMC Health Serv Res. 2014;14:32. doi: 10.1186/1472-6963-14-32.
    1. Yeji F, Klipstein-Grobusch K, Newell M-L, Hirschhorn LR, Hosegood V, Bärnighausen T. Are social support and HIV coping strategies associated with lower depression in adults on antiretroviral treatment? Evidence from rural KwaZulu-Natal, South Africa. AIDS Care. 2014;0:1–8.
    1. Kim J, Han JY, Shaw B, McTavish F, Gustafson D. The roles of social support and coping strategies in predicting breast cancer patients’ emotional well-being testing mediation and moderation models. J Health Psychol. 2010;15:543–52. doi: 10.1177/1359105309355338.
    1. García-Moreno C, Jansen HAFM, Ellsberg M, Heise L, Watts C. WHO Multi-Country Study on Women’s Health and Domestic Violence against Women: Initial Results on Prevalence, Health Outcomes and Women’s Responses. Geneva: World Health Organization; 2005.
    1. Chaiyachati K, Hirschhorn LR, Tanser F, Newell M-L, Bärnighausen T. Validating five questions of antiretroviral nonadherence in a public-sector treatment program in rural South Africa. AIDS Patient Care STDs. 2011;25:163–70.
    1. Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical trials group (AACTG) AIDS Care. 2000;12:255–66. doi: 10.1080/09540120050042891.
    1. Carrieri P, Cailleton V, Le Moing V, Spire B, Dellamonica P, Bouvet E, et al. The dynamic of adherence to highly active antiretroviral therapy: results from the French National APROCO cohort. J Acquir Immune Defic Syndr. 2001;28:232–9. doi: 10.1097/00042560-200111010-00005.
    1. Spire B, Carrieri P, Sopha P, Protopopescu C, Prak N, Quillet C, et al. Adherence to antiretroviral therapy in patients enrolled in a comprehensive care program in Cambodia: a 24-month follow-up assessment. Antivir Ther. 2008;13:697–703.
    1. Boyer S, Clerc I, Bonono C-R, Marcellin F, Bilé P-C, Ventelou B. Non-adherence to antiretroviral treatment and unplanned treatment interruption among people living with HIV/AIDS in Cameroon: Individual and healthcare supply-related factors. Soc Sci Med. 2011;72:1383–92. doi: 10.1016/j.socscimed.2011.02.030.
    1. Oyugi JH, Byakika-Tusiime J, Ragland K, Laeyendecker O, Mugerwa R, Kityo C, et al. Treatment interruptions predict resistance in HIV-positive individuals purchasing fixed-dose combination antiretroviral therapy in Kampala, Uganda. AIDS Lond Engl. 2007;21:965–71. doi: 10.1097/QAD.0b013e32802e6bfa.
    1. Holzemer WL, Uys LR, Chirwa ML, Greeff M, Makoae LN, Kohi TW, et al. Validation of the HIV/AIDS Stigma Instrument - PLWA (HASI-P) AIDS Care. 2007;19:1002–12. doi: 10.1080/09540120701245999.
    1. Kroenke K, Spitzer RL, Williams JBW, Löwe B. An Ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics. 2009;50:613–21.
    1. Löwe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, et al. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010;122:86–95. doi: 10.1016/j.jad.2009.06.019.
    1. Spitzer RL, Kroenke K, Williams JW, and the Patient Health Questionnaire Primary Care Study Group Validation and utility of a self-report version of prime-md: The phq primary care study. JAMA. 1999;282:1737–44. doi: 10.1001/jama.282.18.1737.
    1. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9. J Gen Intern Med. 2001;16:606–13. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the patient health questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007;22:1596–602. doi: 10.1007/s11606-007-0333-y.
    1. Duračinský M, Lalanne C, Acquadro C, Hermann S, Lau J, Lecoeur S, et al. Psychometric validation of PROQOL-HIV a contemporaneous and cross-cultural health-related quality-of-life (HRQL) questionnaire specific to HIV. Cape Town: 5th IAS Conf HIV Pathog Treat Prev; 2009.
    1. Theis J, Grady HM. Participatory Rapid Appraisal for Community Development: A Training Manual Based on Experiences in the Middle East and North Africa. London, UK: International Institute for Environment and Development : Save the Children Federation; 1991.
    1. Souville M, Msellati P, Carrieri M-P, Brou H, Tape G, Dakoury G, et al. Physicians’ knowledge and attitudes toward HIV care in the context of the UNAIDS/Ministry of Health Drug Access Initiative in Côte d’Ivoire. AIDS Lond Engl. 2003;17(Suppl 3):S79–86. doi: 10.1097/00002030-200317003-00011.
    1. Wilson D, Taaffe J, Fraser-Hurt N, Gorgens M. The economics, financing and implementation of HIV treatment as prevention: What will it take to get there? Afr J AIDS Res. 2014;13:109–19. doi: 10.2989/16085906.2014.943254.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi