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1.
BMC Public Health ; 24(1): 1876, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39004714

ABSTRACT

BACKGROUND: Multipurpose prevention technologies (MPTs) are products capable of simultaneously addressing multiple sexual and reproductive health needs such as unwanted pregnancy, STIs including HIV-1, and other reproductive tract infections. MPTs are urgently needed to address the double burden of unplanned pregnancy and HIV. While condoms are currently the only accessible MPTs, they are not solely under a woman's control, and female condoms face limitations due to poor acceptability and high cost. METHODS: We conducted a sub-analysis of qualitative data from 39 couples participating in the MTN 045 study to examine the perception of couples on choice and acceptability of a "2 in 1" MPT that combines HIV and pregnancy prevention. RESULTS: Couples recognized the benefits of MPTs for HIV and pregnancy prevention but perceptions tied to each indication and a novel prevention technology tool raised important concerns relevant to use of future MPTs. In the study, participants' perceptions of MPT use were influenced by pregnancy planning. When the timing was less critical, they prioritized HIV prevention. Misinformation about family planning methods, including MPTs, affected decision-making with potential to hinder uptake of future MPTs. Concerns about side effects, such as weight gain and hormonal imbalances, influenced willingness to use MPTs. CONCLUSION: Addressing the myths and misconceptions surrounding the use of contraceptives is crucial in promoting their acceptance and ultimate use. Strategies for addressing the drawbacks women might experience while using a particular product should be in place as new MPTs progress through the development pipeline and approach roll-out.


Subject(s)
HIV Infections , Humans , Female , Male , Adult , HIV Infections/prevention & control , Pregnancy , Qualitative Research , Choice Behavior , Contraception/methods , Contraception/psychology , Young Adult , Health Knowledge, Attitudes, Practice , Family Planning Services
2.
BMC Public Health ; 24(1): 1936, 2024 Jul 19.
Article in English | MEDLINE | ID: mdl-39030487

ABSTRACT

BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples' actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.


Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Qualitative Research , Humans , Zimbabwe , Male , Female , Adult , HIV Infections/prevention & control , Pre-Exposure Prophylaxis/methods , Fertilization , Choice Behavior , Interviews as Topic , Middle Aged , Pilot Projects , Young Adult , HIV Seropositivity/psychology , Pregnancy
3.
AIDS Behav ; 27(1): 198-207, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35776249

ABSTRACT

We conducted a secondary analysis of discrete choice experiment (DCE) data from 395 couples enrolled in the Microbicide Trials Network (MTN)-045/CUPID study in Uganda and Zimbabwe to understand couple decision making around choice of multipurpose prevention technologies (MPTs) to prevent both HIV and pregnancy. Members of couples completed the same DCE, first separately then jointly, choosing between two hypothetical MPTs in a series of nine questions. Most couples either had similar preferences at the outset or had equal decision-making around MPTs (62%). Couples with male influence (17%) were more likely to use contraceptive pills with a male partner's knowledge and couples with female influence (21%) were less likely to have shared decision making about family planning. Males influenced discussion around MPT duration, side effects, menstrual changes, and how the vagina feels during sex. Decision making was relatively shared, though decisions around certain attributes were more likely to be dominated by male partners.


Subject(s)
HIV Infections , Pregnancy , Humans , Male , Female , HIV Infections/prevention & control , Family Planning Services , Decision Making , Uganda , Zimbabwe
4.
AIDS Behav ; 26(3): 996-1005, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34907478

ABSTRACT

Women who acquire HIV during the pregnancy and breastfeeding periods have a higher risk of transmitting the virus to their child than women who become infected with HIV before pregnancy. We explore the context of sexual beliefs and practices that may shape both HIV risk and willingness to use HIV prevention products during pregnancy and postpartum in Malawi, South Africa, Uganda and Zimbabwe. Twenty-three single sex focus group discussions and 36 in-depth interviews took place between May and November 2018 with recently pregnant or breastfeeding women, men, mothers and mothers-in-law of pregnant or breastfeeding women, and key informants. Participants across study groups and sites (N = 232) reported various perceived benefits and harms of sex during pregnancy and postpartum. Participants discussed reasons why men might seek sex outside of the relationship. There is a critical need for alternative prevention options to protect pregnant and breastfeeding women from HIV.


Subject(s)
HIV Infections , Health Knowledge, Attitudes, Practice , Attitude , Female , HIV Infections/epidemiology , HIV Infections/prevention & control , HIV Infections/transmission , Humans , Malawi/epidemiology , Male , Mothers , Pregnancy , South Africa/epidemiology , Uganda/epidemiology , Zimbabwe/epidemiology
5.
AIDS Behav ; 26(12): 3848-3861, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35674885

ABSTRACT

End-user input early in biomedical product development may optimize design to support high uptake and adherence. We interviewed 400 couples (800 total participants) in Uganda and Zimbabwe to assess their preferences for multipurpose prevention technologies (MPTs) for HIV and pregnancy prevention. Using a discrete choice experiment, couples made a series of choices between hypothetical MPTs, including oral tablets and vaginal rings, inserts, and films and completed an interviewer-administered questionnaire assessing sociodemographic and behavioral measures. Most couples preferred presented MPTs over male condoms. Couples' MPT choices in both countries were influenced most by the combination of product form and dosing frequency, with monthly dosing preferred over daily. Analysis highlighted differences by country as to which side effects were most important: Ugandan couples placed greater importance on effects on the vaginal environment during sex, whereas Zimbabwean couples placed more importance on changes to menstruation and other side effects (headache, cramps). Couples' preferences signaled an openness to new product forms and more frequent dosing if preferred characteristics of other attributes were achieved.


Subject(s)
Contraceptive Devices, Female , HIV Infections , Pregnancy , Female , Male , Humans , Zimbabwe/epidemiology , Uganda , Contraception/methods , HIV Infections/prevention & control
6.
Cult Health Sex ; 24(5): 612-626, 2022 05.
Article in English | MEDLINE | ID: mdl-33810781

ABSTRACT

Oral Pre-Exposure Prophylaxis (PrEP) is an established option, and the dapivirine vaginal ring is emerging as a promising strategy for HIV prevention option for women. Because of this, understanding the contextual and cultural factors that will support the increased uptake of these products is crucial. In sub-Saharan Africa, religious leaders may be important stakeholders to involve in product information, education and roll-out. We conducted a sub-analysis of data from 232 participants taking part in the MTN-041/MAMMA study to explore religious leaders' involvement in pregnant and breastfeeding women's health. Study participants viewed biomedicine and spirituality as interlinked and believed that women could seek health-related care from medical experts and turn to faith-based organisations for religious or spiritual needs. Religious leaders were invested in the health of their congregations, endorsed a variety of sexual health strategies, and were eager to learn more about emerging HIV prevention technologies. These data signal the role of religious leaders in supporting their communities, and the importance of involving religious leaders in efforts to roll out new HIV prevention products to facilitate uptake.


Subject(s)
Contraceptive Devices, Female , HIV Infections , Pre-Exposure Prophylaxis , Breast Feeding , Decision Making , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , Pregnancy
7.
Afr J AIDS Res ; 21(4): 354-363, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36538544

ABSTRACT

We examined men's influence on women's interest in biomedical HIV prevention during pregnancy and breastfeeding through structured questionnaires and focus group discussions with currently or recently pregnant and breastfeeding (P/BF) women (n = 65), men with P/BF partners (n = 63) and mothers/mothers-in-law of P/BF women (n = 68) in eastern and southern Africa. Data were transcribed, coded and summarised into analytical memos. Men were depicted by most participants as joint decision-makers and influencers of women's use of HIV prevention. Cultural and religious norms depicting men as heads, breadwinners and protectors of the family were cited to legitimise their involvement in decision-making. Male partner education and engagement were recommended to garner their support in women's HIV prevention. This study elucidates how P/BF women's ability to prevent HIV is shaped by traditional and contemporary gender norms in social settings and locations where the study was conducted. Findings may aid intervention design to engage men for P/BF women's effective use of microbicide and oral PrEP.


Subject(s)
Contraceptive Devices, Female , HIV Infections , Pregnancy , Humans , Male , Female , Sexual Partners , Breast Feeding , HIV Infections/prevention & control , Gender Identity
8.
AIDS Behav ; 25(1): 124-138, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32588257

ABSTRACT

The attributes of an HIV microbicide may affect its acceptability, uptake and use. Quatro, a clinical study with a qualitative component, was conducted to elicit input from end-users and key informants (KIs) on four different placebo vaginal microbicide delivery forms; fast dissolving insert, ring, film and gel. In-depth interviews and focus group discussions were conducted with young women, their male partners and KIs, to explore acceptability and preferences of the four placebo products, with the intention of improving product attributes, adherence, and consequently, long term effectiveness. None of the four microbicide delivery forms stood well above others as the most preferred. Product attributes; long-action, ease of use, invisibility, female initiated and non-interference during sex were favourable in both countries. Despite preference for the long-action, on-demand products were the most liked by women. Qualitative data from the Quatro study provided rich feedback on specific attributes important to the acceptability of four HIV prevention product platforms currently in development, enabling more informed and guided product development efforts moving forward.


Subject(s)
Antiviral Agents , HIV Infections , Administration, Intravaginal , Antiviral Agents/administration & dosage , Disease Transmission, Infectious/prevention & control , Female , HIV Infections/prevention & control , Humans , Male , Patient Acceptance of Health Care , Sexual Partners , South Africa , Zimbabwe
9.
BMC Public Health ; 21(1): 2041, 2021 11 08.
Article in English | MEDLINE | ID: mdl-34749675

ABSTRACT

BACKGROUND: Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use. METHODS: All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs. RESULTS: 2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52). CONCLUSIONS: Our analysis supports the growing body of work illustrating the importance of meaningfully engaging research participants to achieve study success and aligns with other analyses of adherence support efforts during ASPIRE. While causation between PEA attendance and product use cannot be established, residual drug levels in returned rings strongly correlated with participant attendance at PEAs, and the benefits of incorporating PEAs should be considered when designing future studies of investigational products.


Subject(s)
Anti-HIV Agents , Contraceptive Devices, Female , HIV Infections , Anti-HIV Agents/therapeutic use , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Pyrimidines
10.
Women Health ; 60(1): 72-86, 2020 01.
Article in English | MEDLINE | ID: mdl-31043134

ABSTRACT

Socio-cultural beliefs and practices surrounding menses influence women's sexual and reproductive health behaviors and decision-making. We analyzed menstrual experiences within the context of the MTN-020/ASPIRE clinical trial during which women were asked to use a monthly vaginal ring for HIV prevention. The qualitative component of the trial was conducted during February 2013-June 2015, included interviews and focus group discussions with 214 women aged 18-42, in Malawi, Zimbabwe, Uganda, and South Africa. Emotions of shame, embarrassment and disgust relating to menses emerged. Menstruation was referred to using euphemistic terms or language about dirtiness. Women were uncomfortable touching their own menstrual blood when removing vaginal rings and felt embarrassed about study staff seeing blood on returned rings. Despite reassurances, women felt ashamed performing study procedures while menstruating, leading to missed study visits. Women's aversion to menstrual blood was linked to narratives about avoiding sex during menses and beliefs about its potential harms. Women associated men's disgust pertaining to menstrual blood with men's willingness to use condoms for sex only during menses, highlighting another way through which socio-cultural beliefs and practices around menstruation affect HIV protective behaviours. These findings provide novel insight into menstrual shame among women in these four countries.


Subject(s)
Contraceptive Devices, Female , Menstruation/psychology , Shame , Administration, Intravaginal , Adolescent , Adult , Africa South of the Sahara , Anti-HIV Agents/therapeutic use , Female , Focus Groups , HIV Infections/drug therapy , HIV Infections/prevention & control , Health Knowledge, Attitudes, Practice , Humans , Sexual Partners/psychology , Young Adult
11.
BMC Womens Health ; 19(1): 18, 2019 01 25.
Article in English | MEDLINE | ID: mdl-30683103

ABSTRACT

BACKGROUND: In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants. METHODS: VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings. RESULTS: Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception. CONCLUSIONS: Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants. TRIAL REGISTRATION: NCT02358616 ; Posted February 9, 2015, retrospectively registered.


Subject(s)
HIV Infections/prevention & control , Medication Adherence/psychology , Patient Acceptance of Health Care/psychology , Pre-Exposure Prophylaxis/methods , Vaginal Creams, Foams, and Jellies/administration & dosage , Administration, Intravaginal , Adult , Clinical Trials, Phase II as Topic , Female , Humans , Middle Aged , Motivation , Patient Preference , Qualitative Research , Retrospective Studies , Self Report , Surveys and Questionnaires
12.
Cult Health Sex ; 21(11): 1209-1224, 2019 11.
Article in English | MEDLINE | ID: mdl-30657023

ABSTRACT

Rumours may influence health-related behaviours, including the uptake of and adherence to HIV prevention products. This study assessed the safety and effectiveness of a vaginal ring delivering the antiretroviral dapivirine for HIV prevention in Africa. We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe. In total 214 women participated in either single or serial in-depth interviews, or a focus group discussion. Three key findings emerged in the data. Firstly, rumours reflected fears concerning the ring and trial participation. Given the historical-political context of the countries in which the trial was conducted, the ring's investigational nature and its foreign origin, ring use was rumoured to cause negative health outcomes such as cancer and infertility and to be associated with practices such as witchcraft or Satanism. The salience of these rumours varied by country. Secondly, rumours reportedly affected participants' adherence to the ring, and other women's willingness to participate in the study. Finally, participants reported that participant engagement activities helped address rumours, resulting in enhanced trust and rapport between staff and participants.


Subject(s)
Anti-Retroviral Agents/therapeutic use , Contraceptive Devices, Female , Deception , HIV Infections , Patient Acceptance of Health Care , Pyrimidines/therapeutic use , Adult , Female , Focus Groups , HIV Infections/drug therapy , HIV Infections/prevention & control , HIV-1/isolation & purification , Humans , Interviews as Topic , Malawi , South Africa , Zimbabwe
13.
AIDS Behav ; 22(3): 877-886, 2018 03.
Article in English | MEDLINE | ID: mdl-28110473

ABSTRACT

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/psychology , Medication Adherence , Pre-Exposure Prophylaxis , Adult , Female , HIV Infections/epidemiology , Humans , Qualitative Research , Self Report , South Africa/epidemiology , Uganda/epidemiology , Zimbabwe/epidemiology
14.
AIDS Behav ; 18(5): 855-61, 2014 May.
Article in English | MEDLINE | ID: mdl-24158488

ABSTRACT

Use of HIV prevention methods may vary for women by types of sexual partners. In a microbicide safety and effectiveness trial (HPTN 035) differences in adherence to a microbicide study gel were compared between women with new versus ongoing partnerships over time. 1,757 women in the three HPTN 035 trial's arms completed the Follow-up Partner Status (FPS) questionnaire at their last study visit. Women married at baseline were asked if they had the same husband, new husband or new partner. Unmarried women were asked if they had changed partners or married. Self-reported gel adherence during the last sex act was compared at each quarterly visit between women with ongoing versus new partners. High gel adherence was compared with low gel adherence (85-100 vs. <85 % of last vaginal sex acts reported with gel use, respectively) in multivariable models to assess associations with partner change. Overall 7 % of women (n = 123) reported a new partner and 41 % (51) of those reported a new husband. Median gel adherence was reported to be 100 % in women with ongoing partners and 75 % for women with new partners (p < 0.001). In women reporting no gel use in their last sex act, only 12.5 % of the women with a new partner and none of those with an ongoing partner reported using condoms (p < 0.001). Fewer women with new partners reported using both the gel and condom during the last sex act as compared to women with ongoing partners (median 50 vs. 71.4 %, p < 0.001). After adjusting for age, site, education level, and sexual frequency, women with ongoing partners were more likely to report high gel adherence than those with new partners (AOR 2.5, 95 % CI 1.6, 3.9). This pattern persisted when gel use over time was compared between women with new versus ongoing partners. In the HPTN 035 trial, women with new partners had higher HIV incidence and reported less gel use and higher condom use. Specific counseling and support are needed to help women use potential HIV prevention methods, including microbicides, when they are changing partners.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , HIV Infections/prevention & control , Medication Adherence , Sexual Partners , Spouses , Administration, Intravaginal , Adult , Condoms/statistics & numerical data , Female , Follow-Up Studies , Gels , Humans , Male , Middle Aged , Sexual Behavior/statistics & numerical data , Socioeconomic Factors , Surveys and Questionnaires , Young Adult
15.
Sex Reprod Health Matters ; 32(1): 2366587, 2024 Dec.
Article in English | MEDLINE | ID: mdl-39007699

ABSTRACT

Decision-making on childbearing and safer conception use in HIV sero-different couples involves an intricate balance of individual desires and perceived HIV acquisition risk. This paper addresses an important knowledge gap regarding HIV sero-different couples' considerations and the relationship and power dynamics involved when deciding to use a safer conception method. Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples, who exited the SAFER study - a pilot study assessing the feasibility, acceptability and cost-effectiveness of a safer conception programme for HIV sero-different couples in Zimbabwe. All couples in SAFER were provided with a choice of safer conception methods and were followed for up to 12 months of pregnancy attempts and 3 months following pregnancy. While couples generally perceived their safer conception discussions to be easy and consensus-driven, the decision-making process also involved complex gender dynamics and trade-offs in relationship power, which resulted in differing interpretations of what constituted a joint or shared couple decision. Participants regarded effective couple communication as an essential component of and precursor to good safer conception conversations and requested additional training in couple communication. Couples relied on information from healthcare providers to kickstart their safer conception discussions. Safer conception programmes should address relationship power imbalances, promote effective couple communication and offer healthcare provider support to enable HIV sero-different couples to make informed choices about conception in a manner that upholds their safety and reproductive autonomy.


Our study explored how HIV sero-different couples in Zimbabwe made decisions on the use of safer conception methods. We interviewed 14 men and 17 women who participated in the SAFER study ­ a pilot study looking at how feasible, acceptable and cost-effective a safer conception programme for HIV sero-different couples is in Zimbabwe. We sought to understand the relationship dynamics, considerations and power trade-offs involved in choosing a safer conception method. Couples reported that their conversations about safer conception were easy and agreeable. At the same time, we found that both gender norms and HIV status shaped the couples' decision-making process, with male gender and partners with an HIV-negative status often having more influence in the final decision of which method to use. Effective couple communication was deemed crucial to support safer conception conversations, with participants requesting additional training in this area. The findings emphasise the importance of providing safer conception methods in a context that addresses power disparities, fosters good communication and includes healthcare providers' support to uphold HIV sero-different couples' reproductive rights and help them achieve their reproductive goals.


Subject(s)
Decision Making , Fertilization , HIV Infections , Qualitative Research , Humans , Zimbabwe , Male , Female , Adult , HIV Infections/prevention & control , Pilot Projects , Pregnancy , HIV Seropositivity/psychology , Interviews as Topic , Communication
16.
BMJ Open ; 14(3): e075381, 2024 Mar 12.
Article in English | MEDLINE | ID: mdl-38479746

ABSTRACT

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women's sexual and reproductive health needs. We will gauge the DPP's acceptability in two cross-over clinical trials. METHODS AND ANALYSIS: PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16-40 years) and Harare, Zimbabwe (n=30, 16-24 years) will be randomised 1:1 to the order of regimens-DPP or two separate tablets-each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024. ETHICS AND DISSEMINATION: PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand's Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences. TRIAL REGISTRATION NUMBERS: NCT04778514, NCT04778527.


Subject(s)
Contraception , HIV Infections , Pre-Exposure Prophylaxis , Female , Humans , Anti-HIV Agents/therapeutic use , Cross-Over Studies , HIV Infections/epidemiology , HIV Infections/prevention & control , Pre-Exposure Prophylaxis/methods , South Africa/epidemiology , Zimbabwe , Randomized Controlled Trials as Topic , Adolescent , Young Adult , Adult
17.
PLOS Glob Public Health ; 3(2): e0000796, 2023.
Article in English | MEDLINE | ID: mdl-36963004

ABSTRACT

Safer conception services are needed to minimize HIV transmission among HIV sero-different couples desiring pregnancy. Few studies have evaluated the choices couples make when offered multiple safer conception methods or real-world method acceptability and effectiveness. We piloted a comprehensive safer conception program (Clintrials.gov identifier: NCT03049176) for HIV sero-different couples planning pregnancy in Zimbabwe to measure feasibility, method uptake, acceptability, pregnancy outcome, and HIV transmission. This study was not designed to compare rates of HIV transmission by safer conception method choice but rather to understand choices couples make when seeking to minimize risk of HIV transmission and maximize likelihood of pregnancy. Couples in this prospective, non-randomized study were given a choice of one or more currently available safer conception methods: antiretroviral therapy (ART) with monthly viral load (VL) monitoring for the HIV-positive partner (ART/VL), pre-exposure prophylaxis (PrEP) for the HIV-negative partner, vaginal insemination (VI) for couples with an HIV-positive woman, and semen washing (SW) for couples with an HIV-positive man. Couples were followed monthly for up to 12 months of pregnancy attempts, quarterly during pregnancy, and 12 weeks post-partum. At each visit, data on method use, urine for pregnancy testing, and blood for HIV antibody testing, or viral load if HIV-positive, were obtained. Infants born to HIV-positive women were tested for HIV at 6 and 12 weeks. Between March 2017 and June 2019, 46 individuals from 23 HIV sero-different partnerships were enrolled and followed. At enrollment, all couples chose ART/VL, and all couples chose at least one additional method; 74% chose PrEP, 36% chose SW, and 25% chose VI. During pre-pregnancy follow-up visits, three couples discontinued SW, and one couple discontinued VI; all four of these couples opted for ART/VL plus PrEP. Satisfaction with safer conception methods was high among those who chose ART/VL and PrEP. Twelve couples achieved pregnancy. There were no cases of HIV transmission to partners, and no infants tested positive for HIV. This safer conception program is feasible and acceptable, allowing sero-different couples to safely achieve pregnancy. Sero-different couples in Zimbabwe seek a combination of HIV prevention methods, particularly ART/VL plus PrEP. Trial Registration: Clintrials.gov, NCT03049176.

18.
AIDS Behav ; 16(3): 785-90, 2012 Apr.
Article in English | MEDLINE | ID: mdl-21863339

ABSTRACT

This paper presents empirical data on motivation to join an HIV prevention trial of vaginal microbicide gels in Malawi and Zimbabwe, and participant assumption of a preventive misconception. Interviews were conducted with women participating in the trial and their male partners. Most of the female participants were able to adequately describe basic aspects of the trial design. HIV counseling and testing were primary reasons motivating women's participation, and male partners' support of the trial. 29% of women and 20% of men also provided indications of a preventive misconception, attributing gel use and trial participation to avoiding HIV infection.


Subject(s)
Clinical Trials, Phase II as Topic/psychology , HIV Infections/prevention & control , Health Knowledge, Attitudes, Practice , Medication Adherence/psychology , Motivation , Patient Participation/psychology , Randomized Controlled Trials as Topic/psychology , Acrylic Resins/administration & dosage , Anti-HIV Agents/administration & dosage , Clinical Trials, Phase II as Topic/methods , Double-Blind Method , Female , HIV Infections/psychology , HIV Infections/transmission , Humans , Interviews as Topic , Malawi , Male , Naphthalenesulfonates/administration & dosage , Polymers/administration & dosage , Randomized Controlled Trials as Topic/methods , Sexual Partners/psychology , Zimbabwe
19.
AIDS Behav ; 16(7): 1799-807, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22782791

ABSTRACT

Duet® is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.


Subject(s)
Acrylic Resins/administration & dosage , Anti-Infective Agents/administration & dosage , Contraceptive Devices, Female/statistics & numerical data , Patient Preference/statistics & numerical data , Acrylic Resins/adverse effects , Adolescent , Adult , Anti-Infective Agents/adverse effects , Coitus , Contraceptive Devices, Female/adverse effects , Cross-Over Studies , Drug Delivery Systems/psychology , Female , Humans , Male , Patient Acceptance of Health Care , Patient Preference/psychology , Sexual Partners , Socioeconomic Factors , Time Factors , Urban Population , Young Adult , Zimbabwe
20.
J Int AIDS Soc ; 25(10): e26024, 2022 10.
Article in English | MEDLINE | ID: mdl-36254362

ABSTRACT

INTRODUCTION: Young women in sub-Saharan Africa account for two-thirds of all new HIV infections and face high rates of unintended pregnancy. Multipurpose prevention technologies (MPTs) are promising products under development that are designed to simultaneously prevent HIV and unintended pregnancy. Since MPTs will be used in the context of sexual relationships, ensuring acceptability and use requires understanding the role of male partners in MPT use decision-making. METHODS: This paper draws on qualitative data from 39 couples enrolled in the Microbicide Trials Network (MTN) 045 study, conducted in 2019-2020. Partners completed a discrete choice experiment (DCE), first separately and then jointly, to measure preferences for future MPT attributes and then completed a qualitative interview. We also draw on quantitative data from interviewer observation about who dominated the decision-making process during the joint DCE. Content analysis was used to examine (1) how couples made decisions on existing non-MPT HIV and pregnancy prevention products; (2) how couples made decisions on future ideal-MPT product during the DCE; and (3) how these decision-making processes varied by decision-making dominance (10 male, 10 female and 19 equal) and interview type (19 joint and 20 separate). RESULTS: Existing non-MPT product decisions focused on trust between partners and product attributes, while future ideal-MPT product decisions exclusively focused on product attributes. Across existing and future products, preferences for product attributes varied by gender. Male partners were most concerned with limiting side effects impacting sexual pleasure, female partners were most concerned with limiting side effects causing physical symptoms and both were concerned with the return to fertility. Across all dominance and interview types, couples reported making decisions together and female partners were often able to negotiate with male partners for their preferred product or set of product attributes. CONCLUSIONS: Research activities in this study provided an opportunity for couples to openly present their product attribute preferences to their partner, learn about their partner's attribute preferences, negotiate for their ideal set of attributes and ultimately choose attributes that benefited the couple without disempowering the female partner. Future research should focus on the utility of couple-based decision-making aids or similar tools for facilitating joint MPT decision-making.


Subject(s)
Anti-Infective Agents , HIV Infections , Contraception , Female , HIV Infections/prevention & control , Humans , Male , Pregnancy , Pregnancy, Unplanned , Sexual Partners , Technology
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