Oral PrEP uptake, adherence, and persistence during periconception periods among women in South Africa: an intervention study.

OBJECTIVE: We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures. DESIGN: This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12 months. METHODS: We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2 months dosing) were analyzed for a subset of women. RESULTS: Three hundred thirty women with median age 24 (IQR: 22-27) years enrolled. Partner HIV-serostatus was unknown by 96% ( N = 316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12 months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24-7.30]). None had detectable plasma tenofovir. CONCLUSION: The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women. CLINICAL TRIAL NUMBER: NCT03194308.

Sexually Transmitted Infection Prevalence, Partner Notification, and Human Immunodeficiency Virus Risk Perception in a Cohort of Women Completing Sexually Transmitted Infection Screening as Part of a Safer Conception Study.

BACKGROUND: Integrating sexually transmitted infection (STI) and preexposure prophylaxis (PrEP) care may optimize sexual and reproductive health. METHODS: We nested an STI substudy within a human immunodeficiency virus (HIV) prevention cohort (parent study) of 18- to 35-year-old women from South Africa, planning pregnancy with a partner with HIV or of unknown serostatus. Parent-study women completed annual surveys regarding HIV-risk perceptions and were offered oral PrEP. Preexposure prophylaxis initiators completed quarterly plasma tenofovir (TFV) testing. Substudy women completed STI screening at enrollment, 6 months, onset of pregnancy, and in the third trimester via examination, vaginal swabs tested via PCR for Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , Mycoplasma genitalium , and blood tested for Treponema pallidum . Follow-up was 6 months. Women with STIs were treated, offered partner notification (PN) cards, and surveyed regarding PN practices. We describe STI prevalence and incidence, and model factors associated with prevalent infection. Sexually transmitted infection substudy and parent study-only participants were matched on age and number of days on study to assess HIV-risk perception scores between the 2 groups and the proportion with detectable TFV. RESULTS: Among 50 substudy participants, 15 (30%) had prevalent STI. All 13 completing follow-up reported PN. Most did not prefer assisted PN. Mean HIV risk perception scores and proportion with detected plasma TFV were similar across groups. CONCLUSIONS: High STI prevalence supports the importance of laboratory screening to optimize sexual health for women planning pregnancy. Rates of self-reported PN are reassuring; low interest in assisted PN suggests the need for alternative approaches. Enhanced STI care did not affect HIV-risk perception or PrEP adherence, however both were relatively high in this cohort.

Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women.

Background: Daily, oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) reduces HIV acquisition for African women. Adherence is key to efficacy and patterns of adherence can be highly variable in real-world settings. Using group-based trajectory modeling (GBTM), we sought to identify distinct patterns of periconception PrEP adherence and evaluate potential baseline predictors of such adherence trajectories. Methods: We conducted a single-arm longitudinal study for women aged 18-35 years living in Durban, South Africa with personal or partner plans for pregnancy with a partner with HIV or of unknown serostatus. Participants were offered safer conception counseling, including daily oral PrEP; women who initiated PrEP were given a bottle with an electronic pillcap that recorded when device opens. Weekly adherence to daily PrEP was modeled using GBTM with a censored normal outcome distribution as a function of weeks since PrEP initiation. The number and functional form of the adherence trajectory groups were primarily selected based on Bayesian information criteria (BIC) and confirmed by mean estimated probabilities of group membership. A multivariable version of the selected model assessed baseline predictors of membership in adherence trajectory groups. Results: Overall mean (95% CI) adherence to PrEP was 63% (60%, 67%). We identified four groups of women with distinct patterns of adherence: (1) high (i.e., ≥6 doses per week) steady adherence throughout follow-up (22% of PrEP initiators); (2) moderate (i.e., 4-5 doses per week), but steady adherence (31%); (3) initially high, but consistently declining adherence (21%); and (4) initially moderate adherence, followed by a rapid decline and subsequent rebound (26%). In multivariable-adjusted analyses, older age was associated with membership in the high, steady adherence group as compared to the group identified with an adherence trajectory of initially high, then decline, and finally a rebound. Conclusions: GBTM is useful for exploring potential heterogeneity in longitudinal patterns of medication adherence. Although a large proportion of women in this study achieved high levels of adherence by electronic pillcap initially, far fewer women maintained these levels consistently. Knowledge of different adherence trajectories could be used to develop targeted strategies for optimizing HIV prevention during periconception.

A continuum of individual-level factors that influence modern contraceptive uptake and use: perspectives from community members and healthcare providers in Durban, South Africa.

BACKGROUND: South Africa faces numerous sexual and reproductive health challenges that can be mitigated with contraceptive use. Contraceptive use is defined and measured as use, non-use, or discontinued use. Research has shown that there are expanded definitions of use beyond these categories. Identifying such categories may assist in a better understanding of factors that influence contraceptive use. SETTING AND METHODOLOGY: This qualitative study was conducted in the eThekwini Municipality in KwaZulu-Natal, South Africa. The aim was to explore the factors influencing the uptake and use of modern contraception. One hundred and twenty-seven participants were enrolled in this study. One hundred and three of those were community members, and twenty-five were healthcare providers. Focus group discussions and in-depth interviews were conducted to gather the data. Data analysis was facilitated using NVivo 10 software. RESULTS: The data show that numerous factors influence contraceptive uptake and use. From these factors, a continuum of use that captures a variety of states of use emerged. Five different states of use were uncovered: no-use, vulnerable use, compelled use, conditional use, and autonomous use. The development of the model illustrates the complexity of contraceptive needs and that it extends beyond definitions found in policies and large-scale surveys. Expanding conceptions of use can aid in developing counselling and information support tools that can improve the uptake and continued use of modern contraception.

Access to public sector family planning services and modern contraceptive methods in South Africa: A qualitative evaluation from community and health care provider perspectives.

Progress has been made to improve access to family planning services and contraceptive methods, yet many women still struggle to access contraception, increasing their risk for unintended pregnancy. This is also true for South Africa, where over fifty per cent of pregnancies are reported as unintended, even though contraception is freely available. There is also stagnation in the fertility rate indicators and contraceptive use data, indicating that there may be challenges to accessing contraception. This paper explores the evaluation of access to contraception from community and health care provider perspectives. This qualitative study explored factors affecting the uptake and use of contraception through focus group discussions (n = 14), in-depth interviews (n = 8), and drawings. Participants included male and female community members (n = 103) between 15 and 49 years of age, health care providers (n = 16), and key stakeholder informants (n = 8), with a total number of 127 participants. Thematic content analysis was used to explore the data using NVivo 10. Emergent themes were elucidated and thematically categorised. The results were categorised according to a priori access components. Overall, the results showed that the greatest obstacle to accessing contraception was the accommodation component. This included the effects of integrated care, long waiting times, and limited operational hours-all of which contributed to the discontinuation of contraception. Community members reported being satisfied with the accessibility and affordability components but less satisfied with the availability of trained providers and a variety of contraceptive methods. The accessibility and affordability themes also revealed the important role that individual agency and choice in service provider plays in accessing contraception. Data from the illustrations showed that adolescent males experienced the most geographic barriers. This study illustrated the importance of examining access as a holistic concept and to assess each component's influence on contraceptive uptake and use.

Influences on PrEP Uptake and Adherence Among South African Women During Periconception and Pregnancy: A Qualitative Analysis.

Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet PrEP delivery to women in periconception and pregnancy has lagged. We report qualitative research from a study evaluating PrEP use as part of safer conception care for 330 South African women. Fifty-two semi-structured interviews were conducted with 25 study participants to identify influences on PrEP adherence. Influences were: (1) changing proximity to male partners; (2) COVID-19 lockdown; (3) mobile lifestyle; (4) PrEP-related stigma; (5) disclosure of PrEP use; and (6) pregnancy and motherhood. Data also revealed important contextual information shaping adherence influences for women, including: (a) not living with partners, (b) partners as drivers of pregnancy intention, and (c) feeling at high risk for HIV. Disclosure of PrEP use, addressing stigma, strategies for traveling with pills, and counseling on prevention effective adherence are promising components of PrEP-inclusive HIV prevention interventions for South African women who are pregnant or planning pregnancy.

Quality of care in public sector family planning services in KwaZulu-Natal, South Africa: a qualitative evaluation from community and health care provider perspectives.

BACKGROUND: Quality of care is a multidimensional concept that forms an integral part of the uptake and use of modern contraceptive methods. Satisfaction with services is a significant factor in the continued use of services. While much is known about quality of care in the general public health care service, little is known about family planning specific quality of care in South Africa. This paper aims to fill the gap in the research by using the Bruce-Jain family planning quality of care framework. METHODS: This formative qualitative study was conducted in South Africa, Zambia, and Kenya to explore the uptake of family planning and contraception. The results presented in this paper are from the South African data. Fourteen focus group discussions, twelve with community members and two with health care providers, were conducted along with eight in-depth interviews with key informants. Thematic content analysis using the Bruce-Jain Quality of Care framework was conducted to analyse this data using NVIVO 10. RESULTS: Family planning quality of care was defined by participants as the quality of contraceptive methods, attitudes of health care providers, and outcomes of contraceptive use. The data showed that women have limited autonomy in their choice to either use contraception or the method that they might prefer. Important elements that relate to quality of care were identified and described by participants and grouped according to the structural or process components of the framework. Structure-related sub-themes identified included the lack of technically trained providers; integration of services that contributed to long waiting times and mixing of a variety of clients; and poor infrastructure. Sub-themes raised under the process category included poor interpersonal relations; lack of counselling/information exchange, fear; and time constraints. Neither providers nor users discussed follow up mechanisms which is a key aspect to ensure continuity of contraceptive use. CONCLUSION: Using a qualitative methodology and applying the Bruce-Jain Quality of Care framework provided key insights into perceptions and challenges about family planning quality of care. Identifying which components are specific to family planning is important for improving contraceptive outcomes. In particular, autonomy in user choice of contraceptive method, integration of services, and the acceptability of overall family planning care was raised as areas of concern.

Community and Provider Perspectives on Addressing Unmet Need for Contraception: Key Findings from a Formative Phase Research in Kenya, South Africa and Zambia (2015-2016).

Unmet need for contraception remains a challenge especially in low and middle-income countries. Community participation or the -active involvement of affected populations in all stages of decision-making and implementation of policies, programs, and services‖ is a precondition for attaining the highest standard of health. Participation as a key component of rights and quality of care frameworks could increase met needs. However, it has been inadequately addressed in contraceptive programs. A qualitative, exploratory methodology that included focus group discussions and in-depth interviews with community members, healthcare providers, and other stakeholders were conducted to identify domains or key thematic areas of action through which stakeholders could be engaged. The study conducted in Kenya, South Africa, and Zambia explored knowledge and use of contraceptives, barriers and enablers to access, quality of care, and participatory practices. Thematic analysis was used, facilitated by NVivo (version 10 QSR International) with a single master codebook. Comparing the thematic areas that emerged from the county data, four domains were selected: quality of care, informed decision-making, acceptability, and accountability. These domains informed the theory of change of a participatory programme aiming to meet unmet needs. Identifying possible generalizable domains establishes measurable and comparable intermediate outcomes for participatory programs despite diverse African contexts.

"As we have gathered with a common problem, so we seek a solution": exploring the dynamics of a community dialogue process to encourage community participation in family planning/contraceptive programmes.

BACKGROUND: Community dialogues have been widely used as a method for community engagement and participation to cover a broad range of areas. However, there has been limited documentation and evaluation of the process, particularly as a method towards achieving family planning and contraception (FP/C) programme goals. As part of the development of an intervention package aimed at increasing community and health care provider (HCP) participation in the provision of FP/C, feasibility testing of the intervention approach (a community dialogue between communities and health facilities) was carried out. Our findings offer a systematic description and evaluation of the community dialogue process, with key recommendations towards future implementation. METHODS: The dialogue was evaluated in three ways: 1) through participant observation during the community dialogue, 2) via a standardised feasibility testing tick-list for all observers of the dialogue, and 3) through three focus group discussions (FGDs) consisting of different groups of stakeholders who participated in the community dialogue. In total, 28 community members, HCPs, and key stakeholders attended the community dialogue (22 females, 6 males). Twenty-seven of the community dialogue participants participated in one of 3 FGDs held after the dialogue. Six evaluators assessed feasibility of the dialogue process. RESULTS: There was good attendance, representation and participation amongst community and provider sectors based on the participant observations using the standardized feasibility check-list. The community dialogue process received positive feedback in the FGDs and was demonstrated to be feasible and acceptable. Key factors contributing to the success of the community dialogue included a skilled facilitator, good representation of participants, establishing ground rules, good timekeeping, and using a Theory of Change to facilitate goal identification and dialogue. Issues to consider are the underlying power differentials related to age, profession and gender which caused initial feelings of anxiety amongst some participants. CONCLUSIONS: Our formative findings offer a systematic description and evaluation of a community dialogue process with key recommendations that may be considered when constituting similar community dialogues in the future.

Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa.

INTRODUCTION: Women who choose to conceive a baby with a partner living with HIV or a partner whose HIV serostatus is unknown in HIV-endemic settings need prevention strategies to mitigate HIV acquisition during conception and pregnancy. METHODS AND ANALYSIS: We are conducting a single-arm longitudinal study offering oral tenofovirdisoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South Africa. PrEP is offered as part of woman-centred safer conception programme that promotes couples-based HIV counselling and testing, antiretroviral therapy for partners who are HIV-infected, treatment for sexually transmitted infections and safer conception strategies, such as limiting condomless sex to peak fertility. We enrol HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a partner living with HIV or of unknown serostatus, and personal or partner plans for pregnancy in the next 12 months. We follow enrolled women for 12 months. Women who become pregnant are followed through pregnancy outcome, independent of their decisions regarding PrEP use. The primary objective of the study is to evaluate the uptake of and adherence to PrEP during the periconception period and pregnancy. Secondary outcomes include the uptake of other safer conception strategies. We also measure clinical outcomes including HIV seroconversion rates and pregnancy and infant outcomes. Finally, we will explore conduct and evaluate qualitative interviews in 25 participants to further inform our conceptual framework for periconception PrEP uptake and adherence among HIV-exposed women in South Africa. ETHICS AND DISSEMINATION: The protocol has been approved by the Human Research Ethics Committee at the University of the Witwatersrand (Johannesburg, South Africa) and the Institutional Review Board of Partners Healthcare (Boston, Massachusetts, USA). Study findings will be made available to interested participants. Results will be presented to local health officials and stakeholders at meetings. Investigators will share the results at meetings and in manuscripts. De-identified quantitative data will be made available. TRIAL REGISTRATION NUMBER: The protocol is registered with the South African Health Products Regulatory Agency (SAHPRA, formerly known as the Medicine Controls Council, MCC#20170131) and ClinicalTrials.gov (NCT03194308); Pre-results.

Male partner influence on family planning and contraceptive use: perspectives from community members and healthcare providers in KwaZulu-Natal, South Africa.

BACKGROUND: South Africa faces numerous reproductive challenges that include high rates of unplanned and adolescent pregnancies. The uptake and utilization of family planning services and modern contraception methods depend on numerous factors. The male partner plays a key role in reproductive health but data on this topic are outdated or have a predominant HIV prevention focus. The purpose of this paper is to explore the influence of male partners on family planning and contraceptive (FP/C) uptake and use within the contemporary South African setting, and to identify further areas of exploration. METHODS: This qualitative study was conducted in a community and healthcare provision setting in the eThekwini District in KwaZulu-Natal province, South Africa. Data were collected from twelve community-based focus group discussions (n = 103), two healthcare providers focus group discussions (n = 16), and eight key informant individual in-depth interviews. Following a constructionist paradigm and using the health utilization behaviour model, data were analysed using thematic analysis, allowing a robust and holistic exploration of the data. RESULTS: The data from this study revealed the complex and evolving role that male partners play in FP/C uptake and use within this setting. Key themes from the data elucidated the dual nature of male involvement in FP/C use. Culturally influenced gender dynamics and adequate understanding of FP/C information were highlighted as key factors that influenced male attitudes and perceptions about contraceptive use, whether positively or negatively. Male opposition was attributed to limited understanding; misunderstandings about side-effects; male dominance in relationships; and physical abuse. These factors contributed to covert or discontinued use by female partners. Pathways identified through which male partners positively influenced FP/C uptake and access include: social support, adequate information, and shared responsibility. CONCLUSIONS: Understanding the role that male partners play in FP/C uptake and use is important in preventing unintended pregnancies and improving family planning policy and service delivery programmes. By identifying the barriers that male partners present, appropriate strategies can be implemented. Equally important is identifying how male partners facilitate and promote adherence and use, and how these positive strategies can be incorporated into policy to improve the uptake and use of FP/C.

Community and provider perspectives on addressing unmet need for contraception: key findings from a formative phase research in Kenya, south Africa and Zambia (2015-2016)

Unmet need for contraception remains a challenge especially in low and middle-income countries. Community participation or the ­active involvement of affected populations in all stages of decision-making and implementation of policies, programs, and services‖ is a precondition for attaining the highest standard of health. Participation as a key component of rights and quality of care frameworks could increase met needs. However, it has been inadequately addressed in contraceptive programs. A qualitative, exploratory methodology that included focus group discussions and in-depth interviews with community members, healthcare providers, and other stakeholders were conducted to identify domains or key thematic areas of action through which stakeholders could be engaged. The study conducted in Kenya, South Africa, and Zambia explored knowledge and use of contraceptives, barriers and enablers to access, quality of care, and participatory practices. Thematic analysis was used,facilitated by NVivo (version 10 QSR International) with a single master codebook. Comparing the thematic areas that emerged from the county data, four domains were selected: quality of care, informed decision-making, acceptability, and accountability. These domains informed the theory of change of a participatory programme aiming to meet unmet needs. Identifying possible generalizable domains establishes measurable and comparable intermediate outcomes for participatory programs despite diverse African contexts

Community and health systems barriers and enablers to family planning and contraceptive services provision and use in Kabwe District, Zambia.

BACKGROUND: Unmet need for contraception results in several health challenges such as unintended pregnancies, unwanted births and unsafe abortions. Most interventions have been unable to successfully address this unmet need due to various community and health system level factors. Identifying these inhibiting and enabling factors prior to implementation of interventions forms the basis for planning efforts to increase met needs. This qualitative study was part of the formative phase of a larger research project that aimed to develop an intervention to increase met needs for contraception through community and health system participation. The specific study component reported here explores barriers and enablers to family planning and contraceptive services provision and utilisation at community and health systems levels. METHODS: Twelve focus group discussions were conducted with community members (n = 114) and two with healthcare providers (n = 19). Ten in-depth interviews were held with key stakeholders. The study was conducted in Kabwe district, Zambia. Interviews/discussions were translated and transcribed verbatim. Data were coded and organised using NVivo 10 (QSR international), and were analysed using thematic analysis. RESULTS: Health systems barriers include long distances to healthcare facilities, stock-outs of preferred methods, lack of policies facilitating contraceptive provision in schools, and undesirable provider attitudes. Community level barriers comprise women's experience with contraceptive side effects, myths, rumours and misconceptions, societal stigma, and negative traditional and religious beliefs. On the other hand, health systems enablers consist of political will from government to expand contraceptive services access, integration of contraceptive services, provision of couples counselling, and availability of personnel to offer basic methods mix. Functional community health system structures, community desire to delay pregnancy, and knowledge of contraceptive services are enablers at a community level. CONCLUSIONS: These study findings highlight key community and health systems factors that should be considered by policy, program planners and implementers in the design and implementation of family planning and contraceptive services programmes, to ensure sustained uptake and increased met needs for contraceptive methods and services.