Evidence map›Paper›PMID 27959766›Full record

Trial reportThe New England journal of medicine2016

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women.

Annalene Nel, Neliëtte van Niekerk, Saidi Kapiga, Linda-Gail Bekker, Cynthia Gama, Katherine Gill, Anatoli Kamali, Philip Kotze, Cheryl Louw, Zonke Mabude and 24 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 300 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
300citing papers in PubMed, 8 pooled it
37.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01539226 nacompletednot on this map

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

TypeinterventionalSponsorInternational Partnership for Microbicides, Inc.Ran2012 to 2016Enrolled1,959ConditionsHIV InfectionsArmsPlacebo Vaginal Ring, Dapivirine Vaginal Ring, 25 mg
NCT05516602 nacompletednot on this mapstarted 2023, after this paper: background citation

Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda

TypeinterventionalSponsorMRC/UVRI and LSHTM Uganda Research UnitRan2023 to 2024Enrolled394ConditionsHIV-1-infectionArmsPeer Support
3 · Its place in the literature

Who cites it

300 citing papers in PubMed, 8 syntheses or guidelines pooled it, 457 citations in OpenAlex.

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  3. Global HIV Incidence Analysis and Implications for Affordability Using Long-Acting Cabotegravir Versus Continuous and Event-Driven Oral Preexposure Prophylaxis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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  6. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  7. Topical microbicides for preventing sexually transmitted infections.The Cochrane database of systematic reviews · 2021
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240 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors at 6 institutions in 7 countries.

Annalene NelFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Neliëtte van NiekerkFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Saidi KapigaFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Linda-Gail BekkerFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Cynthia GamaFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Katherine GillFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Anatoli KamaliFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Philip KotzeFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Cheryl LouwFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Zonke MabudeFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Nokuthula MitiFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Sylvia KusemererwaFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Hugo TempelmanFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Hannelie CarstensFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Brid DevlinFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Michelle IsaacsFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Mariëtte MalherbeFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Winel MansFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Jeremy NuttallFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Marisa RussellFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Smangaliso NtsheleFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Marlie SmitFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Leonard SolaiFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Patrick SpenceFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
John SteytlerFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Kathleen WindleFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Maarten BorremansFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Sophie ResselerFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Jens Van RoeyFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Wim ParysFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Tony VangeneugdenFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Ben Van BaelenFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Zeda RosenbergFrom International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
Ring Study Team
Mwanza Intervention Trials Unit · TZInternational Partnership for Microbicides · USChild, Adolescent and Family Mental Health · CADesmond Tutu HIV Foundation · ZAUganda Virus Research Institute · UGUniversity of Pretoria · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda.

methodsIn this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion.

resultsA total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P=0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified.

conclusionsAmong women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226 .).

Indexed as

HIV-1HIV SeropositivityAdolescentAdultDouble-Blind MethodDrug Resistance, ViralFemaleHIV InfectionsHumansIncidenceMiddle AgedPregnancyPyrimidinesReverse Transcriptase InhibitorsRNA, ViralSouth AfricaDapivirinePyrimidinesReverse Transcriptase InhibitorsRNA, Viral

Identifiers

PMID27959766
OpenAlexW2558446330

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