Table 1 List of papers and Weight of Evidence Review
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 |