Why are so few HIV/AIDS trials conducted in Africa?

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Why are so few HIV/AIDS trials conducted in Africa?

30 Sep 2005

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People in sub-Saharan Africa carry the heaviest burden of HIV and

AIDS, yet very few trials have been conducted on the African continent

over the past two decades, say researchers in this week's BMJ.

This study confirms previous findings that HIV/AIDS trials are

under-represented in sub-Saharan research and suggests that

publication of trial results continues to be driven by researchers

external to the continent.

The team identified and mapped all randomised controlled trials on HIV

and AIDS conducted wholly or partly in Africa and reported before 2004.

After extensive searching, they identified 77 trials published or

reported from 1987 to 2003.

Most of the trials were funded by government agencies outside Africa,

pharmaceutical companies and international non-government or

inter-government organisations. Few principal investigators were based

in African countries and there was no mention of ethical approval or

informed consent in 19 and 17 trials, respectively.

The relatively small number of HIV/AIDS trials conducted in Africa is

not commensurate with the burden of disease, say the authors. This may

reflect a lack of economic ability, political will, or research capacity.

Geographical mapping as an adjunct to prospective trial registration

is a useful tool for researchers and decision makers to track existing

and future trials, they conclude.

Randomised controlled trials in Africa of HIV and AIDS: descriptive

study and spatial distribution BMJ Volume 331, pp 742-6

Josip Car, Tim Stokes, , and Fletcher for

important comments made on an earlier version of this paper.

Contributors: See bmj.com

Funding: Occasional student maintenance grants from the London

School of Economics Financial Office.

Competing interests: None declared.

Ethical approval: Ghana Medical School ethics committee.

1 Kroeger A. Anthropological and socio-medical health care research in

developing countries. Soc Sci Med 1983;17:147-61.

2 Green EC. Sexually transmitted disease, ethnomedicine and health policy

in Africa. Soc Sci Med 1992;35:121-30.

3 Kirby JP. The Islamic dialogue with African traditional religion:

divination

and healthcare. Soc Sci Med 1993;36:237-47.

4 Nkwi PN. Perceptions and treatment of diarrhoeal diseases in Cameroon.

J Diarrhoeal Dis Res 1994;12:35-41.

5 Rekdal OB. Cross-cultural healing in east African ethnography. Med

Anthropol Q 1999;13:458-82.

6 GW. What do sequential behavioural patterns suggest about the

medical decision-making process? Modeling home case management of

acute illness in a rural Cameroonian village. Soc Sci Med 1998;46:209-25.

7 Nyamwaya D. A case study of the interaction between indigenous and

Western medicine among the Pokot of Kenya. Soc Sci Med 1987;25:

1277-87.

8 Unwin N, Setel P, Rashid S, Mugusi F, Mbanya J, Kitange H, et al.

Noncommunicable diseases in sub-Saharan Africa: where do they feature

in the health research agenda? Bull World Health Org 2001;79:947-53.

9 DeJong J. Traditional medicine in Sub-Saharan Africa: its importance and

potential policy options.Washington, DC:World Bank, 1991.

10 Monitoring and Evaluation Team. Formative and baseline research on

diabetes

mellitus in Ghana. Accra: Ghana Diabetes Care and Disease

Management Project, 1998.

11 Amoah AGB, Owusu KO, Adjei S. Diabetes in Ghana: a community

prevalence study in Greater Accra. Diabetes Res Clin Pract 2002;56:

197-205.

12 Ofei F, Forson A, Appia-Kusi J. Self-care behaviour amongst Ghanaian

diabetics. Unpublished conference paper available from Dr Francis Ofei,

University of Ghana Medical School, PO Box 4236, Accra, Ghana, 1996.

13 De-Graft Aikins A. Living with diabetes in rural and urban Ghana: a

critical

social psychological examination of illness action and scope for

intervention.

J Health Psychol 2003;8:557-72.

14 De-Graft Aikins A. Social representations of diabetes in Ghana:

reconstructing self, society and culture. Unpublished PhD thesis. London

School of Economics and Political Science, 2004.

15 Rose D, Efraim D, Gervais M, Joffe H, Jovchelovitch S, Morant N.

Questioning consensus in social representations theory. Papers on Social

Representations 1995;4(2):1-155.

16 Moscovici S, Duveen G. Social representations: explorations in

social psychology.

New York: New York University Press, 2000.

17 Bediako K. Africa and Christianity on the threshold of the third

millennium.

African Affairs 2000;99:303-23.

18 Government of Ghana (Ministry of Health). The health of the nation:

analysis

of health sector programme of work: 1997-2001. Accra: Ministry of Health,

2001.

19 De-Graft Aikins A. Exploring biomedical and ethnomedical

representations

of diabetes in Ghana and the scope for cross-professional collaboration:

a social psychological approach to health policy. Social Science

Information 2002;41:603-30.

20 De-Graft Aikins. Strengthening quality and continuity of diabetes

care in

rural Ghana: a critical social psychological approach. J Health Psychol

2004;9:295-309.

21 Valente TW,Watkins SC, Jato MN, van der Straten A, Tsitol LP.

Social network

associations with contraceptive use among Cameroonian women in

voluntary associations. Soc Sci Med 1997;45:677-87.

22 Krause M. The transformation of social representations of chronic

disease in a self-help group. J Health Psychol 2003;8:599-615.

Randomised controlled trials in Africa of HIV and AIDS:

descriptive study and spatial distribution

Nandi Siegfried, Mike e, Jimmy Volmink

Abstract

Objectives To identify and describe randomised

controlled trials on HIV and AIDS conducted in

Africa and to map their spatial distribution using

exact geographic coordinates.

Design Construction and analysis of a database of

trials conducted wholly or partly in Africa and

reported before 2004.

Data sources CENTRAL, Medline, Embase, and

LILACS.

Results Our comprehensive search yielded 284

distinct records that were potentially eligible for

inclusion in the database. Of these, 150 articles

reported on 77 eligible trials published or reported

from 1987 to 2003. Seven trials were identified

exclusively from the CENTRAL database. Trials were

conducted in 18 of 48 countries in sub-Saharan

Africa. None were conducted in north Africa. Only 19

had a principal investigator located in an African

country. Forty two trials assessed prevention and 35

assessed treatment. Most studies were funded by

government agencies outside Africa (n = 43), with the

pharmaceutical industry providing partial support to

16 of these. The pharmaceutical industry provided

full or partial support to a further 18 trials. Only 43

trials reported conducting a power calculation for

determining sample size. There was no mention of

ethical approval or informed consent in 19 and 17

trials, respectively.

What is already known on this topic

Healer shopping is the primary and dominant practice for Africans

with chronic illness and is a function of culturally mediated spiritual

beliefs and the need for cures

People abandon biologically centred biomedicine and gravitate

towards ethnomedical systems because ethnomedicine is deemed to

provide cures for spiritually caused conditions

Problematic ethnomedical treatment methods undermine self care and

biomedical goals

What this study adds

Ethnomedical healer shopping within the Ghanaian diabetes context is

a secondary practice, coexisting with biomedical management, spiritual

action, and medical inaction

Spiritual causal theories exist but are secondary to biological and

lifestyle theories; ethnomedicine is consulted for cheaper

pharmacological, rather than spiritual, treatment

Healthcare goals are undermined by high cost of prescribed drugs and

foods, poor psychosocial support, and unregulated ethnomedical and

faith healer treatments

The search terms and the full list of references for included

trials can be found on bmj.com

This is an abridged version. The full version is on bmj.com

Papers

UK Cochrane

Centre, Oxford

OX2 7LG

Nandi Siegfried

South African

Nuffield medical

fellow

Mike e

director

Primary Health

Care Directorate,

University of Cape

Town, Cape Town,

South Africa

Jimmy Volmink

professor

Correspondence to:

N Siegfried

nsiegfried@

cochrane.co.uk

BMJ 2005;331:742–6

742 BMJ VOLUME 331 1 OCTOBER 2005 bmj.com

Conclusion The relatively small number of

HIV/AIDS trials conducted in Africa is not

commensurate with the burden of disease.

Geographical mapping as an adjunct to prospective

trial registration is a useful tool for researchers and

decision makers to track existing and future trials.

Introduction

The randomised controlled trial is the best study

design to determine whether an intervention is

effective.1 Wherever possible, decisions to use particular

interventions should be based on evidence from

well conducted randomised trials. Over two million

Africans died from AIDS in 2003, and women and

children are disproportionately represented in this figure.

2 People with HIV and AIDS, clinicians, policy

makers, health activists, and many other key players

require information on the most effective forms of

prevention and treatment relevant to their setting.

Researchers and funders of research also require

knowledge of current trials to better address gaps and

disparities in research.3 4

We have assembled a database of African-based trials

of prevention and treatment interventions for HIV

and AIDS as part of a larger study to compare the

methods of these trials with those conducted

elsewhere. We have described all African trials

reported before the end of 2003.

Methods

We identified all records pertaining to HIV or AIDS in

PubMed (see bmj.com) and added a sensitive filter to

identify all possible reports of relevant randomised trials.

5 We searched the Central Register of Controlled

Trials (CENTRAL) (issue 2, 2004); the National Library

of Medicine Medline database (via PubMed on 16

August 2004); Embase via OVID (on 4 September

2004); and Latin American and Caribbean Health Sciences

Literature (LILACS) (on 4 December 2004).

Searching these databases in the second half of

2004 allowed us to capture all reports up to 2003 by

avoiding the delay between reporting and indexing in

the database. The search was not limited by language.

We included LILACS to increase our yield of trials

from Portuguese speaking Africa and Embase to

improve coverage of journals in European languages

other than English.

One of us (NS) read each abstract to determine eligibility

(table 1). Two experienced hand searchers

screened all the retrieved abstracts for controlled trials,

regardless of location. One of us (MC) checked the

sample they identified for any African randomised

controlled trials as a quality control measure. We

obtained full articles of all potentially eligible trials and

those about which we were uncertain. NS read these

articles, determined final eligibility, and extracted data

using a standardised form developed specifically for

this project (see bmj.com). The data were entered on a

specifically designed MSAccess database.

Analysis

Data are presented as numbers and simple frequencies

calculated in MS Excel. Descriptive statistics and qualitative

information are presented when appropriate.

Mapping

For trial location, we recorded the geographic coordinates

of each trial and used geographic mapping

software (MapInfo) to plot the position of each trial.

Results

Search results

We retrieved 440 records from CENTRAL, 47 from

LILACS, 7734 from PubMed, and 4594 from Embase.

We identified 284 discrete potentially eligible records

from all the searches and obtained the full articles. The

reliability of rating between NS and MC was > 91%.

After reading each article, NS identified 150 articles

dealing with a total of 77 randomised controlled trials

(see bmj.com for full list of trials and articles).

Article details

Sixty eight of the 77 trials were reported in articles

retrieved by the PubMed search, either exclusively

(three) or in combination with the CENTRAL and

Embase searches. We retrieved seven trials exclusively

from CENTRAL and two exclusively from Embase. No

eligible articles were retrieved from LILACS.

We identified 71 of the 77 trials from full journal

articles. Three of the trials were reported only in

conference proceedings, and three were identified

from news articles retrieved in the searches with additional

information being obtained directly from the

original authors (three of these trials are unpublished).

A large proportion of the 150 articles were published

in the journals Lancet (n = 28) and AIDS (n = 28).

Twelve articles appeared in the Journal of Acquired

Immune Deficiency Syndrome, and five articles each in the

Journal of Infectious Diseases, Clinical Infectious Diseases,

and the New England Journal of Medicine. The rest were

published in 50 other journals and indexed news

bulletins. Four of these were from the French journals

of Santé, Revue des Maladies Respiratoires, les de la

Société Belge de Médecine Tropicale, and Pathologie et

Biologie. Thirty trials had been published in more than

one article, with one trial of micronutrient supplementation

to prevent mother-to-child transmission being

published in nine different articles.6

Principal investigators

Not every trial clearly reported the identity of the principal

investigator. When we were uncertain, we

classified the first author of the main trial report as the

principal investigator. The principal investigator was

based in the United States for 23 trials and in the

United Kingdom for eight trials. Other principal inves-

Table 1 Eligibility criteria for randomised controlled trials included

in database

Inclusion criteria Exclusion criteria

Intervention Efficacy or effectiveness of HIV/AIDS

specific intervention, including pilot studies

Safety and acceptability trials

Efficacy or effectiveness of non-HIV/AIDS

specific intervention, but with subgroup of

at least 5% (n>10) HIV positive

participants

Trials assessing behavioural interventions

without measuring HIV incidence

Location Conducted wholly in Africa, or partly if

multinational trial

Trials conducted on Africans living outside

continent

Participants Infected with HIV-1, HIV-2 or dually

infected, or in case of prevention trials, HIV

negative, but at risk of HIV

Trial date Reported before 2004 (if preliminary data

only, authors contacted)

Papers

743 BMJ VOLUME 331 1 OCTOBER 2005 bmj.com

tigators based outside Africa were from Australia (1),

Belgium (3), Canada (3), Denmark (1), France (4),

Ireland (3), Germany (2), Sweden (1), Switzerland (1),

and the Netherlands (4). The principal investigators

based within Africa were from Côte d'Ivoire (4), Kenya

(2), Malawi (2), South Africa (4), Zambia (3), and

Zimbabwe (4).We could not identify the location of the

principal investigator for two trials.

Trial characteristics

Forty two trials assessed prevention interventions and

35 were treatment trials.

For prevention, we categorised interventions to

reduce transmission from mother to child (13); drugs

for preventing opportunistic infections (12); microbicides

(5); behavioural interventions (5); drugs for

preventing HIV transmission (such as treatment of

sexually transmitted infection) (4); and other prevention

measures (such as nutritional supplements) (3).

We did not find any completed trials of vaccine efficacy.

Treatment trials included drug treatment of HIV

and AIDS (7); drug treatment of opportunistic infections

(12); drug treatment of other infections in people with

HIV and AIDS (11); and other treatments (such as nutritional

supplementation) (5). None of the trials assessed

behavioural treatments for HIV and AIDS.

The earliest trial started in 1987 and assessed the

preventive efficacy of a microbicide, nonoxinol 9 gel,

among 138 women in Nairobi, Kenya.7 Two other studies,

both conducted in what was then Zaire (now the

Democratic Republic of Congo), began before 1990.8 9

Start dates were uncertain for 15 trials, and the 59

remaining trials began during the 1990s or early 2000s.

Location and mapping

Figures 1 and 2 show the location of the trials categorised

according to prevention or treatment. Trials have

been conducted in 18 of the 48 countries of

sub-Saharan Africa with no trials in north Africa. Forty

two trials were single centre studies and 25 were multicentre

trials done within a single African country. Nine

trials were multinational multicentre trials, five of

which took place in more than one African country.

The four other trials were conducted across continents.

Sample size and quality of methods

Sample size ranged from 16 participants in a nutritional

supplement trial conducted in a rural area of Uganda10

to 39 836 participants in a trial assessing a pneumococcal

conjugate vaccine in HIV positive and HIV negative

children in Soweto, South Africa.11 In 43 trials authors

reported conducting an a priori power calculation, but

this was unclear or not reported in the other trials.

Sixty eight trials compared two interventions or

strategies, five included three comparison groups, two

included four, one included five, and one had six. All,

apart from one crossover trial, used a parallel

randomised design. Simple randomisation was reported

in 33 trials and simple stratified randomisation in one

trial. Forty three reported using blocked or blocked

stratified randomisation. Most trials (73) were randomised

at the individual level. Four were cluster trials,

three of which were large prevention trials (with more

than 12 000 participants) assessing the effectiveness of

both pharmaceutical and behavioural treatment for

sexually transmitted infections on preventing HIV

transmission.12–14 Cluster correlation coefficients were

used in the analyses of all three trials. A smaller prevention

trial of peer education in 2219 factory workers in

Zimbabwe was also cluster randomised but did not

report using a cluster correlation coefficient in its analysis.

15 Thirteen trials reporting on mother to child

transmission were all randomised at the individual level.

0 500 km

Africa

Fig 1 Randomised controlled trials of prevention of HIV and AIDS,

1987-2003. Circles

indicate site of trial based on geographic coordinates. N=42 (some

trials have more than one

country location)

0 500 km

Africa

Fig 2 Randomised controlled trials of treatment of HIV and AIDS,

1987-2003. Circles indicate

site of trial based on geographic coordinates. N=33 (coordinates were

not available for two

trials)

Papers

744 BMJ VOLUME 331 1 OCTOBER 2005 bmj.com

Funding and ethics

We could not identify the primary funder for every

trial—for example, when trials were funded by more

than one source. Government agencies outside of Africa

provided funding to 43 trials (table 2). The pharmaceutical

industry provided full or partial funding, or

provided drugs and placebo treatments, to 34 trials. Sixteen

of the trials that were funded by governments

outside Africa also received funding from the pharmaceutical

industry. Twenty three trials received funding

from international non-government and intergovernment

agencies such as theWorld Health Organization

and UNAIDS. African government agencies and

African non-government agencies provided funding to

five trials. Funding was not reported for four treatment

trials and one prevention trial.

Fifty eight trials reported receiving ethical approval

from an approving authority, with 39 trials receiving

approval from both local African and non-African

institutions. Nineteen trials did not report on ethical

approval; of which 13 were treatment trials and 10

were trials of drugs. Informed consent was obtained in

writing in 34 trials, orally in 7 trials, and by unspecified

methods in 19 trials. Consent was not reported in the

17 other trials.

Discussion

This is the first comprehensive attempt to identify and

describe all randomised controlled trials on HIV and

AIDS conducted in Africa up to 2003. It is innovative in

displaying the extent and scope of the trials graphically

by linking the data directly to geographic coordinates.

This provides an immediate and accessible overview of

the current status of trial evidence.

Strengths and weaknesses

A major strength of our study is the extremely broad

search and the lack of language restrictions. We

contacted authors for additional information for the

small number of trials that were described only in news

articles and expect that contacting the authors of every

trial would yield additional information.16 A thorough

search of conference proceedings might also be useful.

Although recent research has shown that conference

abstracts might not accurately summarise subsequent

full reports,17 the fact that about half the research

reported at conferences does not get published in full

might make such abstracts a useful source of additional

trials.18

The 10/90 disequilibrium

A remarkable finding from our study is how few HIV/

AIDS trials have been conducted on the African continent

over the past two decades. It highlights the gulf

between the global burden of disease and research on

intervention, the so called 10/90 disequilibrium,19–21

and confirms previous findings that HIV/AIDS trials

are under-represented in sub-Saharan research.22 Most

of the trials were funded by government agencies outside

Africa, followed by pharmaceutical companies and

international non-government and inter-government

organisations. This may reflect a lack of economic ability,

political will, or research capacity to conduct intervention

research in African countries. Commercial

funding is a source of potential bias in trials and may

influence results.23 24 Although we are not aware of any

evidence to link non-commercial agency sponsorship

to biased results, research funded by such organisations

may be driven by priorities different from those

of the country where the trial is done.25 26

Few principal investigators were based in African

countries, although it is possible that a proportion of

principal investigators were of African origin and

working abroad.27 Despite this uncertainty, it suggests

that publication of trial results continues to be driven

by researchers external to the continent. It is difficult to

predict how this impacts on African collaborating

researchers, but it does suggest that transfer of skills

and knowledge to local researchers must remain a fundamental

aim of any trial conducted in Africa.25

Table 2 Details of non-African government agencies providing

trial funding

Country and government agency

No of trials

funded/agency*

Australia:

AUSAid 1

Australian National Council of AIDS 1

National Centre in HIV Epidemiology and Clinical Research 1

Austria:

International Atomic Energy Agency 1

Belgium:

Belgian Administration for Development and ation 2

National Fonds voor Wetenschappelijk Onderzoek 1

Canada:

Medical Research Council 3

Ontario HIV Treatment Network 1

Canadian Infectious Diseases 1

Denmark:

Danish International Development Assistance 1

France:

French agency of research on AIDS (ANRS) 4

Ministry of ation 3

Germany:

Centre for International Migration and Development 1

Japan:

Ministry of Education, Science and Culture 1

Netherlands:

Royal Netherlands Embassy of Zambia 1

Dutch Ministry of Welfare, Health and Sport 1

Sweden:

Swedish International Development ation Agency 1

Swedish Heart and Lung Foundation 1

Swedish Research Council 1

United Kingdom:

British Council 1

Medical Research Council 4

Overseas Development Fund 2

Department of International Development 3

United States:

National Institutes of Health (NIH):

Fogarty International Center 7

HIV Network for Prevention Trials 1

National Institute of Allergy and Infectious Diseases 3

National Institute of Child Health and Human

Development

3

World AIDS Foundation 1

NIH grant to Family Health International 1

Veterans' Affairs Research Service

Center for Diseases Control and Prevention, Atlanta 4

US Agency for International Development 5

Armed Forces Institute of Pathology 1

Europe:

European Commission 3

*Numbers are not exclusive as some agencies cofund the same trial.

Papers

745 BMJ VOLUME 331 1 OCTOBER 2005 bmj.com

Ethical issues

Nineteen of the 77 trials did not report on whether ethical

approval had been obtained. Although this may simply

reflect inadequate reporting, it is also possible that

ethical approvalmay not have been obtained. In a survey

of 203 researchers living in developing countries, Hyder

and colleagues found that 44% of respondents reported

that their studies did not undergo any review (technical,

scientific, or ethical) in the country where the study was

done.28 They argued that ethical review in both the host

and the donor country should be standard in collaborative

research. Only half of the HIV/AIDS trials in Africa

met this standard.

Conclusions

A major challenge for a database such as that created

in this study is keeping up to date so as to provide

useful information for patients, carers, clinicians,

researchers, and policy makers. To facilitate this, we

endorse prospective trial registration, which will make

key trial information accessible to the public at no

charge.29 30 In addition, we recommend that those

responsible for trial registers should consider including

geographic coordinates for the trial to allow

graphical display of geographic data.

We are grateful to the authors who provided us with additional

information on their trials. We thank Anne Eisinga for her

assistance with the development and conduct of the searches,

and Tara Horvath for article retrieval, Karishma

Busgeeth for French translations, and Rutherford for

Portuguese translations. We are indebted to Nigel of the

Oxford Bodleian mapping room for assistance with the

geographic information system software.

Contributors: NS had the original idea to compare trial quality

of HIV/AIDS trials in different locations. NS developed the

study design under the supervision ofMC and JV, conducted the

data collection and analysis, wrote the first draft of the paper,

and is guarantor. MC monitored and checked data collection.

All authors contributed to the interpretation of results and

edited the manuscript for important scientific content.

Funding: Nandi Siegfried is sponsored by the Nuffield

Dominions Trust.

Competing interests: None declared.

Ethical approval: Not required.

1 Schulz KF, Grimes DA. Generation of allocation sequences in

randomised trials: chance, not choice. Lancet 2002;359:515-9.

2 UNAIDS. 2004 report on the global AIDS epidemic. Geneva: Joint United

Nations Programme on HIV/AIDS, 2004.

3 -Block MA. Health policy and systems research agendas in

developing countries. Health Res Policy Syst 2004;2:6.

4 Fraser D. Overlooked opportunities for investing in health research and

development. Bull World Health Organ 2000;78:1054-61.

5 Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for

systematic reviews. BMJ 1994;309:1286-91.

6 FawziWW,Msamanga G, Hunter D, Urassa E, Renjifo B,Mwakagile D, et al.

Randomized trial of vitamin supplements in relation to vertical

transmission of HIV-1 in Tanzania. J Acquir Immune Defic Syndr 2000;23:

246-54.

7 Kreiss J, Ngugi E, Holmes K, Ndinya-Achola J, Waiyaki P, PL, et

al. Efficacy of nonoxynol 9 contraceptive sponge use in preventing

heterosexual acquisition of HIV in Nairobi prostitutes. JAMA

1992;268:477-82.

8 Nyst MJ, Perriens JH, Kimputu L, Lumbila M, AM, Piot P. Gentian

violet, ketoconazole and nystatin in oropharyngeal and esophageal

candidiasis

in Zairian AIDS patients. Ann Soc Belg Med Trop 1992;72:45-52.

9 Perriens JH St Louis ME, Mukadi YB, Brown C, Prignot J, Pouthier F, et

al. Pulmonary tuberculosis in HIV-infected patients in Zaire. A controlled

trial of treatment for either 6 or 12 months. N Engl J Med 1995;332:

779-84.

10 Byrne D, Mathias P, Mulvaney M, Male-Kawuma M. The effect of

nutritional supplementation on weight and clinical management of

patients with human immunodeficiency virus (HIV) infection in rural

Uganda. Proc Nutr Soc 1999;58:154A.

11 Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N.

A trial of a 9-valent pneumococcal conjugate vaccine in children with and

those without HIV infection. N Engl J Med 2003;349:1341-8.

12 Grosskurth H, Mosha F, Todd J, Mwijarubi E, Klokke A, Senkoro K, et al.

Impact of improved treatment of sexually transmitted diseases on HIV

infection in rural Tanzania: randomised controlled trial. Lancet

1995;346:530-6.

13 Wawer MJ, Sewankambo NK, Serwadda D, Quinn TC, Paxton LA,

Kiwanuka N, et al. Control of sexually transmitted diseases for AIDS

prevention

in Uganda: a randomised community trial. Rakai Project Study

Group. Lancet 1999;353:525-35.

14 Kamali A, Quigley M, Nakiyingi J, Kinsman J, Kengeya-Kayondo J, Gopal

R, et al. Syndromic management of sexually-transmitted infections and

behaviour change interventions on transmission of HIV-1 in rural

Uganda: a community randomised trial. Lancet 2003;361:645-52.

15 Bassett M. Impact of peer education on HIV infection in Zimbabwe. Sex

Health Exch 1998;4:14-5.

16 Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori VM,

Schünemann HJ, et al. An observational study found that authors of

randomized

controlled trials frequently use concealment of randomization

and blinding, despite the failure to report these methods. J Clin

Epidemiol

2004;57:1232-6.

17 Hopewell S. Trials reported as abstracts and full publications: how do

they compare? [abstract]. Clinical Trials 2004;1(suppl 1):216-7.

18 Scherer R, Langenberg P, von Elm E. Full publication of research

results

initially presented in abstracts. Cochrane Database of Methodology Rev

2005;(2):CD000005.

19 World Health Organization. Investing in health research and

development:

report of the ad hoc committee on health research relating to future

intervention

options. Geneva:WHO, 1996.

20 Nuffield Council on Bioethics. The ethics of research related to

healthcare in

developing countries. London: Nuffield Council on Bioethics, 2002.

21 Yusuf S. Clinical research and trials in developing countries. Stat Med

2002;21:2859-67.

22 Isaakidis P, Swingler GH, Pienaar E, Volmink J, Ioannidis JPA. Relation

between burden of disease and randomised evidence in sub-Saharan

Africa: survey of research. BMJ 2002;324:702-5.

23 Lexchin J, Bero LA, Djulbegovic B, O. Pharmaceutical industry

sponsorship and research outcome and quality: systematic review. BMJ

2003;326:1167-70.

24 Bhandari M, Busse JW, Jackowski D, Montori VM, Schunemann H,

Sprague S, et al. Association between industry funding and statistically

significant pro-industry findings in medical and surgical randomized

trials.

CMAJ 2004;170:477-80.

25 Edejer T. North-South research partnerships: the ethics of carrying out

research in developing countries. BMJ 1999;319:438-41.

26 Anonymous. Brazil leads from the front on AIDS. Lancet 2005;365:1664.

27 Bhandari M, Busse JW, Kulkarni AV, Devereaux PJ, Leece P, Guyatt GH.

Interpreting authorship order and corresponding authorship. Epidemiology

2004;15:125-6.

28 Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical

review of health research: a perspective from developing country

researchers. J Med Ethics 2004;30:68-72.

29 De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al.

Clinical trial registration: a statement from the international committee

of medical journal editors. Lancet 2004;364:911-2.

30 Krleza-Jeric K, Chan A, Dickersin K, Sim I, Grimshaw J, Gluud C.

Principles

for international registration of protocol information and results

from human trials of health related interventions: Ottawa statement

(part 1). BMJ 2005;330:956-8.

What is already known on this topic

People living in sub-Saharan Africa carry the heaviest burden of

HIV and AIDS, with an estimated 25 million individuals infected

with HIV

Randomised trials and systematic reviews of these provide the most

reliable way to assess the relative effects of different interventions for

both prevention and treatment

What this study adds

In the past 20 years, of the many randomised controlled trials on HIV

and AIDS only 77 (42 prevention, 35 treatment) have been conducted

on the African continent and few principal investigators were based in

African countries

Most of the 77 trials were funded by government agencies or

non-governmental organisations outside Africa and by pharmaceutical

companies

Mapping trials with geographic coordinates is a useful tool for

researchers and decision makers to keep track of existing and future

trials

Papers

746 BMJ VOLUME 331 1 OCTOBER 2005 bmj.com

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