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Table 1 List of papers and Weight of Evidence Review

From: Motivations and barriers to uptake and use of female-initiated, biomedical HIV prevention products in sub-Saharan Africa: an adapted meta-ethnography

Author Title Publication Year Product Data Type Study Context Location Population N Study Dates Theory Soundness Appropriateness of study design Relevance Overall Rating
Abrahams, Naeemah & Jewkes, Rachel Barriers to post exposure prophylaxis [PEP] completion after rape: a South African qualitative study 2010 PEP IDIs Stand-alone qualitative South Africa Victims of sexual assault 29 2005-2006 Not specified Medium-High: no theoretical approach articulated for study High: standalone qualitative research High: though an outlier, specifically discusses barriers to PEP use High
Behets, Frieda M T F; Van Damme, Kathleen; Turner, Abigail Norris; Rabenja, Ny Lovaniaina; Ravelomanana, Noro L R; Raharinivo, Mbolatiana S M; Zeller, Kimberly A; Rennie, Stuart M & Swezey, Teri A Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections 2008 Diaphragm FGDs Formative, qualitative Madagascar Female sex workers 266 2004 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a formative research activity, mixed methods Medium-High: qualitative research focusing on acceptability, data on motivations and barriers come through Medium-High
Gafos, Mitzy; Mzimela, Misiwe; Sukazi, Sizakele; Pool, Robert; Montgomery, Catherine & Elford, Jonathan Intravaginal insertion in KwaZulu-Natal: sexual practices and preferences in the context of microbicide gel use 2010 Pro2000 gel IDIs and FGDs MDP 301 Phase III RCT South Africa Sexually active adultwomen/trial participants 136 March 2006 - August 2008 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium-High: qualitative research on vaginal practices Medium-High
Greene, Elizabeth; Batona, Georges; Hallad, Jyoti; Johnson, Sethulakshmi; Neema, Stella & Tolley, Elizabeth E Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India 2010 Celulose Sulfate IDIs Phase III RCT Uganda, Benin High risk women/trial participants 30 Feb-Aug 2007 A variation of the socio-ecological model (Mcleroy et al. 1988) High - all details included Medium-High: qualitative research within a larger trial setting High - specifically evaluates barriers to use of gel among users High
Guest, Greg; Johnson, Laura; Burke, Holly; Rain-Taljaard, Reathe; Severy, Lawrence; von Mollendorf, Claire & Van Damme, Lut Changes in sexual behavior during a safety and feasibility trial of a microbicide/diaphragm combination: an integrated qualitative and quantitative analysis 2008 ACIDFORM Gel and Diaphragm IDIs and FGDs Safety and Feasibility study South Africa Sexually active adult women 120 April 2004 - Nov 2005 Data analysis conducted within a positivist framework (Bernard & Ryan, 1998), no specific theory for study Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trialsetting Medium: paper is focused on changes in sexual behaviour and not motivators/barriers to use, although these come out in the data Medium-High
Guest, G; Shattuck, D; Johnson, L; Akumatey, B; Clarke, E E K; Chen, P & MacQueen, K M Acceptability of PrEP for HIV prevention among women at high risk for HIV 2010 Oral TDF PrEP IDIs Phase III RCT Nigeria, Cameroon, Ghana Sexually active adult women/trial participants 24 June 2004-March 2006 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium-High: qualitative research focusing on acceptability, data on motivations and barriers come through Medium-High
Kacanek, Deborah; Dennis, Amanda; Sahin-Hodoglugil, Nuriye; Montgomery, Elizabeth T; Morar, Neetha; Mtetwa, Sibongile; Nkala, Busi; Phillip, Jessica; Watadzaushe, Connie & Van, der Straten A qualitative study of obstacles to diaphragm and condom use in an HIV prevention trial in sub-Saharan Africa 2012 Diaphragm FGDs MIRA Trial phase III RCT South Africa and Zimbabwe Sexually active adult women/trial participants 206 Aug 2006 - Jan 2007 Modified grounded theory (Glaser & Strauss, 1967) for analysis, no specific theory for study Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium-High: data focused on ability to use condoms with diaphragm, though barriers to use of diaphragm came through Medium-High
Mathenjwa, T & Maharaj, P Female condoms give women greater control’: A qualitative assessment of the experiences of commercial sex workers in Swaziland 2012 Female condom IDIs and FGDs Stand-alone qualitative Swaziland Female sex workers 25 Jan - May 2010 Not specified Medium-High: no theoretical approach articulated for study High: standalone qualitative research High: specifically looks at experiences, motivations and barriers to use of female condom High
Montgomery, C M; Lees, S; Stadler, J; Morar, N S; Ssali, A; Mwanza, B; Mntambo, M; Phillip, J; Watts, C & Pool, R The role of partnership dynamics in determining the acceptability of condoms and microbicides 2008 Pro2000 gel IDIs Component of pilot study for MDP 301 phase III randomized trial South Africa, Tanzania, Uganda and Zambia general population women in couples 45 Not specified none specified (though used relationship based questions and anthropological approaches) Medium: study dates not specified, though can assess date of data collection knowing this was connected with larger MDP301 study; no theoretical approach articulated for the study Medium-High: qualitative research within a pilot for a larger trial High: specifically evaluates experiences of gel use Medium-High
Montgomery, Catherine M; Gafos, Mitzy; Lees, Shelley; Morar, Neetha S; Mweemba, Oliver; Ssali, Agnes; Stadler, Jonathan & Pool, Robert Re-framing microbicide acceptability: findings from the MDP301 trial 2010 Pro2000 gel Semi-structured, serial IDIs Component of MDP 301 phase III randomized trial South Africa, Zambia, Uganda and Tanzania Sexually active adult women/trial participants 464 The trial started in October 2005 and completed followup in August 2009 emic approach to acceptability High: all details included Medium-High: qualitative research within a larger trial setting High: specific to women’s experiences of gel, and their interpretations of use High
van der Straten, A, Montgomery, Elizabeth T; Straten, A; Cheng, H; Wegner, L; Masenga, G; Mollendorf, C; Bekker, L; Ganesh, S; Young, K; Romano, J; Nel, A; Woodsong, C; & von Mollendorf, C High Acceptability of a Vaginal Ring Intended as a Microbicide Delivery Method for HIV Prevention in African Women 2012 Placebo vaginal ring FGDs randomized safety and acceptability study (mixed methods) South Africa and Tanzania Sexually active adult women/trial participants 48 April 2007 to March 2010 Not specified Medium-High: no theoretical approach articulated for study High: qualitativeresearch within a pilot/acceptability study High: specifically aimed at understanding possible motivations and barriers to use of the ring High
Montgomery, Elizabeth T; Chidanyika, Agnes; Chipato, Tsungai; Van, der Straten; Montgomery T, Elizabeth & Ariane Sharing the trousers: gender roles and relationships in an HIV-prevention trial in Zimbabwe 2012 MIRA diaphragm and replens lubricant FGDs and IDIs MIRA Male Involvement Study (ancillary to MIRA trial) Zimbabwe Sexually active adult women/trial participants 85 August 2006 to June 2007 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium: specifically looks at gender roles around decision making in the house and around sex, but experiences with diaphragm come through Medium-High
Okal, Jerry; Stadler, Jonathan; Ombidi, Wilkister; Jao, Irene; Luchters, Stanley; Temmerman, Marleen & Chersich, Matthew F Secrecy, disclosure and accidental discovery: perspectives of diaphragm users in Mombasa, Kenya 2008 Diaphragm IDIs and FGDs prospective study investigating diaphragm continuation rates Kenya Sexually active adult women 39 January 2004 - July 2005 None specified Medium-High: no theoretical approach articulated for study High: standalone qualitative research High: specifically aimed at understanding possible motivations and barriers to use of the diaphragm High
Sahin-Hodoglugil, Nuriye; Montgomery, Elizabeth; Kacanek, Deborah; Morar, Neetha; Mtetwa, Sibongile; Nkala, Busisiwe; Philip, Jessica; Ramjee, Gita; Cheng, Helen; Ariane; SahinHodoglugil, N N; Straten, A & Team, The Mira User experiences and acceptability attributes of the diaphragm and lubricant gel in an HIV prevention trial in southern Africa 2011 MIRA diaphragm and replens lubricant FGDs MIRA Trial phase III RCT Zimbabwe and South Africa Sexually active adult women/trial participants 105 August 2006 to January 2007 None specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting High: specifically evaluates experiences of diaphragm and gel use Medium-High
Stadler, Jonathan & Saethre, Eirik Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial 2011 Pro2000 gel IDIs, FGDs, and participant observation Qualitative research conducted during MDP301 phase III efficacy trial South Africa Sexually active adult women/trial participants 179 women in 401 IDIs, 42 FGDs Trial was completed in August 2008 and follow upcompleted in August 2009 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium-High: examined women’s interpretation and meanings of condom and gel use; leads to motivations and barriers but not explictily examining Medium-High
van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, Schwartz K, Laborde N, Soto-Torres L. Women’s Experiences with Oral and Vaginal Pre-Exposure Prophylaxis: The VOICE-C Qualitative Study in Johannesburg, South Africa. 2014 TDF gel and Oral TDF and Truvada IDIs, serial ethnographic interviews, FGDs, observations Qualitative sub-study in VOICE phase III randomized clinical trial South Africa Sexually active adult women/trial participants 102 July 2010 and August 2012 social-ecological model High: all details included High: qualitative sub-study for larger trial High: specifically examines user experiences of gel and pill use High
Gafos, Mitzy; Pool, Robert; Mzimela, Misiwe Adelaide; Ndlovu, Hlengiwe Beauty; McCormack, Sheena; Elford, Jonathan & Team, M D P The implications of post-coital intravaginal cleansing for the introduction of vaginal microbicides in South Africa 2014 Pro2000 gel serial ethnographic interviews Qualitative research conducted during MDP301 phase III efficacy trial South Africa Sexually active adult women/trial participants 84 March 2006 to August 2008 with follow-up visits continuing until August 2009 Not specified Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium - explores vaginal hygiene practices within context of gel use Medium-High
Lees, S Emergent HIV technology: urban Tanzanian women’s narratives of medical research, microbicides and sexuality 2015 Pro2000 gel IDIs and observations Qualitative research conducted during MDP301 phase III efficacy trial Tanzania Sexually active adult women/trial participants 99 November 2005 to August 2009 None specified (though used anthropological approach) Medium-High: no theoretical approach articulated for study Medium-High: qualitative research within a larger trial setting Medium-High: specifically explores motivations for participating in research, but also includes experiences and interpretations of gel use Medium-High
Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead; Montgomery, Elizabeth; Mathebula, Florence; Hartmann, Miriam & van der Straten, Ariane Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa 2014 TDF gel and Oral TDF and Truvada IDIs and FGDs Qualitative sub-study in VOICE phase III randomized clinical trial South Africa Sexually active adult women/trial participants 102 July 2010 to August 2012 social-ecological model High: all details included High: qualitative sub-study for larger trial High: specifically examines user experiences of gel and pill use High
Montgomery, Elizabeth T; van der Straten, Ariane; Stadler, Jonathan; Hartmann, Miriam; Magazi, Busisiwe; Mathebula, Florence; Laborde, Nicole & Soto-Torres, Lydia Male partner influence on women’s hiv prevention trial participation and use of pre-exposure prophylaxis: The importance of understanding 2015 TDF gel and Oral TDF and Truvada IDIs and FGDs Qualitative sub-study in VOICE phase III randomized clinical trial South Africa Sexually active adult women/trial participants 102 July 2010 to August 2012 social-ecological model High: all details included High: qualitative sub-study for larger trial Medium-High: looked more at partnership dynamics than experiences of product use, but influences of dynamics on use is explored High
Stadler, J; Delany-Moretlwe, S; Palanee, T & Rees, H Hidden harms: women’s narratives of intimate partner violence in a microbicide trial, South Africa 2014 Pro2000 gel serial IDIs Qualitative research conducted during MDP301 phase III efficacy trial South Africa Sexually active adult women/trial participants 401 IDIs with 150 women Not actually specified except “up to 2010” (see other MDP papers) None specified Medium: study dates not specified, though can assess date of data collection knowing this was connected with larger MDP301 study; no theoretical approach articulated for the study Medium-High: qualitative research within a larger trial setting Medium-High: looked more at partnership dynamics than experiences of product use, but influences of dynamics on use is explored Medium-High
Van Der Straten, A; Stadler, J; Luecke, E; Laborde, N; Hartmann, M & Montgomery, E T Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: The VOICE-C qualitative study in Johannesburg, South Africa 2014 TDF gel and Oral TDF and Truvada IDIs and FGDs Qualitative sub-study in VOICE phase III randomized clinical trial South Africa Sexually active adult women/trial participants 102 July 2010 to August 2012 social-ecological model High: all details included High: qualitative sub-study for larger trial High: specifically examines user experiences of gel and pill use, and in particular how meanings of ARVs for prevention can become conflated with treatment and being HIV + High