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
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Care | Study protocol

Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa

Authors: Heidi van Rooyen, Tawanda Makusha, Phillip Joseph, Thulani Ngubane, Michal Kulich, Michael Sweat, Thomas Coates

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men.

Methods

This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load.

Discussion

A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men’s individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.

Trial registration

ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.
Appendix
Available only for authorised users
Literature
1.
Cornell M, McIntyre J, Myer L. Men and antiretroviral therapy in Africa: our blind spot. Tropical Med Int Health. 2011;16(7):828–9.CrossRef
2.
Shand T, Thomson‐de Boor H, van den Berg W, Peacock D, Pascoe L. The HIV blind spot: men and HIV testing, treatment and care in sub‐Saharan Africa. IDS Bulletin. 2014;45(1):53–60.CrossRef
3.
4.
Mills EJ, Ford N, Mugyenyi P. Expanding HIV care in Africa: making men matter. Lancet. 2009;374(9686):275–6.PubMedCrossRef
5.
UNAIDS. Reaching out to men and boys: Addressing the blind spot in the response to HIV. Geneva: UNAIDS; 2017.
6.
7.
Tanser F, Bärnighausen T, Grapsa E, Zaidi J, Newell M-L. High coverage of ART associated with decline in risk of HIV acquisition in rural KwaZulu-Natal, South Africa. Science. 2013;339(6122):966–71.PubMedPubMedCentralCrossRef
8.
UNAIDS. Fact sheet on HIV among men in South Africa. Geneva: UNAIDS; 2018.
9.
Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet. 2013;381(9879):1783–7.PubMedCrossRef
10.
Jeftha A. The construction of masculinity and risk-taking behaviour among adolescent boys in seven schools in the Western Cape. Cape Town: University of the Western Cape; 2006.
11.
12.
Fox MP, Pascoe SJ, Huber AN, Murphy J, Phokojoe M, Gorgens M, et al. Assessing the impact of the National Department of Health’s National Adherence Guidelines for Chronic Diseases in South Africa using routinely collected data: a cluster-randomised evaluation. BMJ Open. 2018;8(1):e019680.PubMedPubMedCentralCrossRef
13.
14.
Higgins JA, Hoffman S, Dworkin SL. Rethinking gender, heterosexual men, and women's vulnerability to HIV/AIDS. Am J Public Health. 2010;100(3):435–45.PubMedPubMedCentralCrossRef
15.
16.
Pascoe L, Peacock D, Stemple L. Reaching Men: Addressing the Blind Spot in the HIV Response. Int J Mens Soc Community Health. 2018;1(Spec Iss 1):e57–70.CrossRef
17.
Druyts E, Dybul M, Kanters S, Nachega J, Birungi J, Ford N, et al. Male sex and the risk of mortality among individuals enrolled in antiretroviral therapy programs in Africa: a systematic review and meta-analysis. AIDS. 2013;27(3):417–25.PubMedCrossRef
18.
Johannessen A. Are men the losers of the antiretroviral treatment scale-up? AIDS. 2011;25(9):1225–6.PubMedCrossRef
19.
Barker GT, Ricardo C, Nascimento M. Engaging Men and Boys in Changing Gender-based Inequity in Health: Evidence from Programme Interventions. Geneva: World Health Organization; 2007.
20.
Bila B, Egrot M. Gender asymmetry in healthcare-facility attendance of people living with HIV/AIDS in Burkina Faso. Soc Sci Med. 2009;69(6):854–61.PubMedCrossRef
21.
Reardon CA, Govender K. “Shaping up”: The relationship between traditional masculinity, conflict resolution and body image among adolescent boys in South Africa. Vulnerable Children Youth Stud. 2011;6(1):78–87.CrossRef
22.
Dageid W, Govender K, Gordon SF. Masculinity and HIV disclosure among heterosexual South African men: implications for HIV/AIDS intervention. Cult Health Sex. 2012;14(8):925–40.PubMedCrossRef
23.
Jewkes R, Morrell R. Gender and sexuality: emerging perspectives from the heterosexual epidemic in South Africa and implications for HIV risk and prevention. J Int AIDS Soc. 2010;13(1):6.PubMedPubMedCentralCrossRef
24.
MacPherson P, MacPherson EE, Mwale D, Squire SB, Makombe SD, Corbett EL, et al. Barriers and facilitators to linkage to ART in primary care: a qualitative study of patients and providers in Blantyre, Malawi. J Int AIDS Soc. 2012;15(2):18020.PubMedPubMedCentralCrossRef
25.
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.PubMedPubMedCentralCrossRef
26.
McNairy ML, El-Sadr WM. The HIV care continuum: no partial credit given. AIDS. 2012;26(14):1735–8.PubMedCrossRef
27.
Foster S, Nakamanya S, Kyomuhangi R, Amurwon J, Namara G, Amuron B, et al. The experience of “medicine companions” to support adherence to antiretroviral therapy: quantitative and qualitative data from a trial population in Uganda. AIDS Care. 2010;22(sup1):35–43.PubMedPubMedCentralCrossRef
28.
Thomas F. Stigma, fatigue and social breakdown: exploring the impacts of HIV/AIDS on patient and carer well-being in the Caprivi Region, Namibia. Soc Sci Med. 2006;63(12):3174–87.PubMedCrossRef
29.
Larsson EC, Thorson A, Nsabagasani X, Namusoko S, Popenoe R, Ekström AM. Mistrust in marriage-Reasons why men do not accept couple HIV testing during antenatal care-a qualitative study in eastern Uganda. BMC Public Jealth. 2010;10(1):769.CrossRef
30.
Koo K, Makin JD, Forsyth BW. Barriers to male-partner participation in programs to prevent mother-to-child HIV transmission in South Africa. AIDS Educ Prev. 2013;25(1):14–24.PubMedPubMedCentralCrossRef
31.
Knox J, Sandfort T, Yi H, Reddy V, Maimane S. Social vulnerability and HIV testing among South African men who have sex with men. Int J STD AIDS. 2011;22(12):709–13.PubMedPubMedCentralCrossRef
32.
Snow R, Madalane M, Poulsen M. Are men testing? Sex differentials in HIV testing in Mpumalanga Province, South Africa. AIDS care. 2010;22(9):1060–5.PubMedCrossRef
33.
Orne-Gliemann J, Tchendjou PT, Miric M, Gadgil M, Butsashvili M, Eboko F, et al. Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study. BMC Public Health. 2010;10(1):197.PubMedPubMedCentralCrossRef
34.
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(5):e267–77.PubMedPubMedCentralCrossRef
35.
Barker G, Ricardo C, Nascimento M, Olukoya A, Santos C. Questioning gender norms with men to improve health outcomes: evidence of impact. Global Public Health. 2010;5(5):539–53.PubMedCrossRef
36.
Pulerwitz J, Michaelis A, Verma R, Weiss E. Addressing gender dynamics and engaging men in HIV programs: lessons learned from Horizons research. Public Health Rep. 2010;125:282–92.PubMedPubMedCentralCrossRef
37.
Verma RK, Pulerwitz J, Mahendra V, Khandekar S, Barker G, Fulpagare P, et al. Challenging and changing gender attitudes among young men in Mumbai, India. Reprod Health Matters. 2006;14(28):135–43.PubMedCrossRef
38.
Pulerwitz J, Barker G, Segundo M, Nascimento M. Promoting more gender-equitable norms and behaviors among young men as an HIV/AIDS revention strategy. Washington, DC: Population Council; 2006.
39.
Ditlopo P, Mullick S, Askew I, Vernon R, Maroga E, Sibeko S, et al. Testing the effectiveness of the Men as Partners program (MAP) in Soweto, South Africa. FRONTIERS Final Report. Washington, DC: Population Council; 2007.CrossRef
40.
Tedrow VA, Zelaya CE, Kennedy CE, Morin SF, Khumalo-Sakutukwa G, Sweat MD, et al. No “magic bullet”: exploring community mobilization strategies used in a multi-site community based randomized controlled trial: Project Accept (HPTN 043). AIDS Behav. 2012;16(5):1217–26.PubMedPubMedCentralCrossRef
41.
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505.PubMedPubMedCentralCrossRef
42.
Lippman SA, Chinaglia M, Donini AA, Diaz J, Reingold A, Kerrigan DL. Findings from Encontros: a multi-level STI/HIV intervention to increase condom use, reduce STI, and change the social environment among sex workers in Brazil. Sex Transm Dis. 2012;39(3):209–16.PubMedPubMedCentralCrossRef
43.
Reza-Paul S, Beattie T, Syed HUR, Venukumar KT, Venugopal MS, Fathima MP, et al. Declines in risk behaviour and sexually transmitted infection prevalence following a community-led HIV preventive intervention among female sex workers in Mysore, India. AIDS. 2008;22:S91–S100.PubMedCrossRef
44.
Ramesh B, Beattie TS, Shajy I, Washington R, Jagannathan L, Reza-Paul S, et al. Changes in risk behaviours and prevalence of sexually transmitted infections following HIV preventive interventions among female sex workers in five districts in Karnataka state, south India. Sex Transm Infect. 2010;86(Suppl 1):i17–24.PubMedCrossRef
45.
Dworkin SL, Hatcher AM, Colvin C, Peacock D. Impact of a gender-transformative HIV and antiviolence program on gender ideologies and masculinities in two rural, South African communities. Men Masc. 2013;16(2):181–202.CrossRef
46.
Mansfield AK, Addis ME, Mahalik JR. “Why won’t he go to the doctor?”: The psychology of men's help seeking. Int J of Men’s Health. 2003;2(2):93.CrossRef
47.
Skovdal M, Campbell C, Madanhire C, Mupambireyi Z, Nyamukapa C, Gregson S. Masculinity as a barrier to men’s use of HIV services in Zimbabwe. Global Health. 2011;7(1):13.PubMedPubMedCentralCrossRef
48.
Pettifor A, Lippman SA, Gottert A, Suchindran CM, Selin A, Peacock D, et al. Community mobilization to modify harmful gender norms and reduce HIV risk: results from a community cluster randomized trial in South Africa. J Int AIDS Soc. 2018;21(7):e25134.PubMedPubMedCentralCrossRef
49.
Sweat M, Morin S, Celentano D, Mulawa M, Singh B, Mbwambo J, et al. Community-based intervention to increase HIV testing and case detection in people aged 16-32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, HPTN 043): a randomised study. Lancet Infect Dis. 2011;11(7):525–32.PubMedPubMedCentralCrossRef
50.
Baral S, Burrell E, Scheibe A, Brown B, Beyrer C, Bekker L-G. HIV risk and associations of HIV infection among men who have sex with men in peri-urban Cape Town, South Africa. BMC Public Health. 2011;11(1):766.PubMedPubMedCentralCrossRef
51.
Beyrer C, Baral S, Kerrigan D, El-Bassel N, Bekker L-G, Celentano DD. Expanding the space: inclusion of most-at-risk populations in HIV prevention, treatment, and care services. J Acquir Immune Defic Syndr. 2011;57(Suppl 2):S96.PubMedPubMedCentralCrossRef
52.
Van Rooyen H, McGrath N, Chirowodza A, Joseph P, Fiamma A, Gray G, et al. Mobile VCT: reaching men and young people in urban and rural South African pilot studies (NIMH Project Accept, HPTN 043). AIDS Behav. 2013;17(9):2946–53.PubMedCrossRef
53.
Govindasamy D, van Schaik N, Kranzer K, Wood R, Mathews C, Bekker L-G. Linkage to HIV care from a mobile testing unit in South Africa by different CD4 count strata. J Acquir Immune Defic Syndr. 2011;58(3):344.PubMedPubMedCentralCrossRef
54.
Tumwebaze H, Tumwesigye E, Baeten JM, Kurth AE, Revall J, Murnane PM, et al. Household-based HIV counseling and testing as a platform for referral to HIV care and medical male circumcision in Uganda: a pilot evaluation. PLoS One. 2012;7(12):e51620.PubMedPubMedCentralCrossRef
55.
Lee R, Cui RR, Muessig KE, Thirumurthy H, Tucker JD. Incentivizing HIV/STI testing: a systematic review of the literature. AIDS Behav. 2014;18(5):905–12.PubMedPubMedCentralCrossRef
56.
57.
58.
Nglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker L-G. An incentivized HIV counseling and testing program targeting hard-to-reach unemployed men in Cape Town, South Africa. J Acquir Immune Defic Syndr. 2012;59(3):e28.PubMedPubMedCentralCrossRef
59.
Eichler R, Levine R. Performance incentives for global health: potential and pitfalls. Center for Global Development Books: Washington D.C; 2009.
60.
Currie MJ, Schmidt M, Davis BK, Baynes AM, O'Keefe EJ, Bavinton TP, et al. ‘Show me the money’: financial incentives increase chlamydia screening rates among tertiary students: a pilot study. Sex Health. 2010;7(1):60–5.PubMedCrossRef
61.
Chacko MR, Cromer BA, Phillips SA, Glasser D. Failure of a lottery incentive to increase compliance with return visit for test-of-cure culture for Neisseria gonorrhoeae. Sex Transm Dis. 1987;14(2):75–8.PubMedCrossRef
62.
Malotte CK, Ledsky R, Hogben M, Larro M, Middlestadt S, Lawrence JSS, et al. Comparison of methods to increase repeat testing in persons treated for gonorrhea and/or chlamydia at public sexually transmitted disease clinics. Sex Transm Dis. 2004;31(11):637–42.PubMedCrossRef
63.
Haukoos JS, Witt MD, Coil CJ, Lewis RJ. The effect of financial incentives on adherence with outpatient human immunodeficiency virus testing referrals from the emergency department. Acad Emerg Med. 2005;12(7):617–21.PubMedCrossRef
64.
Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, et al. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008;8(1):272.PubMedPubMedCentralCrossRef
65.
Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive–based approaches for weight loss: a randomized trial. JAMA. 2008;300(22):2631–7.PubMedPubMedCentralCrossRef
66.
Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, et al. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009;360(7):699–709.PubMedCrossRef
67.
Adato M, Hoddinott J. Conditional cash transfers in Latin America. International Food Policy Research Institute: Washington D.C; 2010
68.
Pettifor A, MacPhail C, Nguyen N, Rosenberg M. Can money prevent the spread of HIV? A review of cash payments for HIV prevention. AIDS Behav. 2012;16(7):1729–38.PubMedPubMedCentralCrossRef
69.
Schwartz S, Lambert A, Phaswana-Mafuya N, Kose Z, Mcingana M, Holland C, et al. Engagement in the HIV care cascade and barriers to antiretroviral therapy uptake among female sex workers in Port Elizabeth, South Africa: findings from a respondent-driven sampling study. Sex Transm Infect. 2017;93(4):290–6.PubMedCrossRef
70.
Enane LA, Vreeman RC, Foster C. Retention and adherence: global challenges for the long-term care of adolescents and young adults living with HIV. Curr Opin HIV AIDS. 2018;13(3):212–9.PubMedCrossRef
71.
Kranzer K, Zeinecker J, Ginsberg P, Orrell C, Kalawe NN, Lawn SD, et al. Linkage to HIV care and antiretroviral therapy in Cape Town, South Africa. PLoS Ine. 2010;5(11):e13801.CrossRef
72.
73.
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(1):18809.PubMedPubMedCentralCrossRef
74.
Wanyenze RK, Kamya MR, Fatch R, Mayanja-Kizza H, Baveewo S, Szekeres G, et al. Abbreviated HIV counselling and testing and enhanced referral to care in Uganda: a factorial randomised controlled trial. Lancet Glob Health. 2013;1(3):e137–e45.PubMedPubMedCentralCrossRef
75.
Department of Health. National HIV Testing Services Policy. Pretoria: Department of Health; 2016.
76.
Muula AS, Ngulube TJ, Siziya S, Makupe CM, Umar E, Prozesky HW, et al. Gender distribution of adult patients on highly active antiretroviral therapy (HAART) in Southern Africa: a systematic review. BMC Public Health. 2007;7(1):63.PubMedPubMedCentralCrossRef
77.
Sidibé M, Loures L, Samb B. The UNAIDS 90–90–90 target: a clear choice for ending AIDS and for sustainable health and development. J Int AIDS Soc. 2016;19(1):21133.PubMedPubMedCentralCrossRef
78.
Cooke GS, Tanser FC, Bärnighausen TW, Newell M-L. Population uptake of antiretroviral treatment through primary care in rural South Africa. BMC Public Health. 2010;10(1):585.PubMedPubMedCentralCrossRef
79.
Leclerc-Madlala S. Age-disparate and intergenerational sex in southern Africa: the dynamics of hypervulnerability. AIDS. 2008;22:S17–25.PubMedCrossRef
Metadata
Title
Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa
Authors
Heidi van Rooyen
Tawanda Makusha
Phillip Joseph
Thulani Ngubane
Michal Kulich
Michael Sweat
Thomas Coates
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3908-0

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial

Study protocol

Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial

Study protocol

Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial

Research

Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing?

Study protocol

Multicenter randomized study on the comparison between electronic and traditional chest drainage systems

Correction

Correction to: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial