Contraception Studies

Community and provider driven social accountability intervention (CaPSAI study): Process evaluation

An intervention was implemented in Ghana and Tanzania to improve uptake and use of family planning and contraceptive methods and services. This intervention used social accountability in community and healthcare providers, to improve uptake and use of these services. The evaluation aims to answer the following research questions:

  1. What factors facilitate or hinder the implementation of the intervention in the study intervention facilities per country?
  2. Was the intervention delivered as intended (per protocol) and did it reach the target audiences of health care providers, duty bearers, citizens and health service users? (Dose, reach and fidelity of the intervention)?

The role of MRU is to co-ordinate and provide support to the research partners conducting the process evaluation research activities in the two countries. MRU is co-ordinating data management and analysis activities for conducting a comprehensive process evaluation.

 

Funder/Sponsor: WHO
Principal Investigator: Cecilia  Milford  (MRU)
Site: Ghana and Tanzania

 

 

Female Condom Contraceptive (CoCo) Study

Female Condom Contraceptive (CoCo) Study

This randomized comparative prospective follow-up study aims to evaluate contraceptive effectiveness of the Cupid, Cupid 2 and FC2  female condoms.   The contraceptive effectiveness will be determined for 6 months. The volunteers will be followed-up monthly for up to seven months. The primary endpoint will be the occurrence of pregnancy or use of emergency contraception, and the diary information will allow pregnancy rates to be characterised by patterns of condom use and failures (contraceptive efficacy and effectiveness rates).  The study commenced enrolment in November 2019 and a total of 780 women will take part in the study.

Funder/Sponsors: Cupid Ltd & FC2
Principal Investigator Mags Beksinska (MRU)
Jenni Smit (MRU)
Ivana Beesham (MRU)
Co-Investigators
Site: MRU, Durban
A Functional Performance Study of The Wondaleaf Female Condom
A Functional Performance Study of The Wondaleaf Female Condom

Following a pilot function  study in 2017, this main function study was  a two-period, cross-over randomized  trial to determine the functional performance, safety and acceptability of the Wondaleaf female condom in comparison to the FC2 female condom.

220 women were enrolled into the study. Each woman was asked to use five Wondaleaf FCs and five FC2  female condoms  (available in the South African public sector). Women were asked to complete a Condom Log at home which gathered data on experience after use of each condom Function, safety, and acceptability was assessed at two follow-up visits approximately one month apart after enrolment. Data collection was completed in Oct 2019 and data analysis is underway.

 Results are expected in the 1st quarter of 2020

Funder/Sponsors: Twin Catalyst, Malaysia
Principal Investigator Dr M Beksinska (MRU)

Dr Ivana Beesham (MRU)

Site: MRU, Durban

 

The Women’s Health, Injectable Contraception and HIV study: randomized comparison of immunological, hormonal, physiological, psychological and behavioural effects of NET-EN versus DMPA contraception (WHICH STUDY)

The Women’s Health, Injectable Contraception and HIV study: randomized comparison of immunological, hormonal, physiological, psychological and behavioural effects of NET-EN versus DMPA contraception (WHICH STUDY)

The WHICH  study aims to provide robust evidence to inform clinicians, policy-makers, and women about the relative risks and benefits of NET-EN versus DMPA IM with respect to biological, physiological, hormonal, psychological and behavioural effects, and method continuation. The WHICH study was a randomised  trial conducted at 2 research sites i.e. the MRU Commercial City site located in Durban and the ECRU site located in East London. In South Africa.    The study commenced  in 2018 and data collection was completed in 2019. Data analysis is  currently underway.

Funder/Sponsors: South African Medical Research Council
Principal Investigator Dr Mandisa Singata-Madliki, (ECRU) Prof Jenni Smit,  (MRU) Prof Janet Patricia Hapgood (UCT)
Co-Investigators Dr Joanne Batting, (ECRU) Prof Mags Beksinska (MRU)
Site: Effective Care Research Unit (ECRU), East London

MRU, Durban

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CUBE: Contraceptive use dynamics beyond the ECHO trial: Assessment of long-term user experiences and method continuation in South Africa
CUBE: Contraceptive use dynamics beyond the ECHO trial: Assessment of long-term user experiences and method continuation in South Africa

This study is a prospective observational longitudinal study that aims to expand the evidence base on contraceptive method discontinuation by gathering information on method experience, contraceptive use dynamics, and access to long acting reversible contraception removal services following exit from the ECHO trial. The study commenced in December 2018 and has recruited 434 women who have exited the ECHO study on either DMPA, Jadelle implant or the Copper IUD from the MRU Edendale and Commercial City sites. Participants will be followed up for up to 24 months.  The study will obtain information about contraceptive continuation rates, reasons for contraceptive discontinuation, implant and IUD removal outcomes, and barriers to implant and IUD removal access. Study is ongoing

Funder/Sponsors: FHI360
Principal Investigator Dr Rebecca Callahan, PhD FHI360, Prof Jenni Smit, PhD  (MRU)
Co-Investigators Mags Beksinska, PhD (MRU)
Site: UNC Kamwala Site, Lusaka, Zambia

MRU, Durban and Edendale sites

Contraceptive use dynamics beyond the ECHO trial: Assessment of long-term user experiences and method continuation in South Africa
Contraceptive use dynamics beyond the ECHO trial: Assessment of long-term user experiences and method continuation in South Africa

This study is a prospective observational longitudinal study that aims to expand the evidence base on contraceptive method discontinuation by gathering information on method experience, contraceptive use dynamics, and access to long acting reversible contraception removal services following exit from the ECHO trial. The study is expected to start in December 2018 and will recruit 550 women who have exited the ECHO study on either DMPA, Jadelle implant or the Copper IUD from the MRU Edendale and Commercial City sites. Participants will be followed up for up to 24 months.  The study will obtain information about contraceptive continuation rates, reasons for contraceptive discontinuation, implant and IUD removal outcomes, and barriers to implant and IUD removal access.

Funder/Sponsors:  FHI360
Principal Investigator Dr Rebecca Callahan, Prof Jenni Smit
Investigators
Site: Effective Care Research Unit (ECRU), East London

MatCH Research Unit (MRU), Commercial City and Edendale sites

Reasons for requesting removal of Implanon implants at an urban reproductive health clinic in KwaZulu-Natal (Implanon Removal Study)

Reasons for requesting removal of Implanon implants at an urban reproductive health clinic in KwaZulu-Natal (Implanon Removal Study)

This cross sectional study  explored reasons for requesting removal of Implanon implants, and patterns of contraceptive use among women presenting to an urban reproductive health clinic.

Beesham, I., Smit, J., Beksinska, M., Panday, M., Makatini, V., Evans, S. (2019). Reasons for requesting removal of the hormonal implant, Implanon NXT at an urban reproductive health clinic in KwaZulu-Natal, South Africa. South African Medical Journal (SAMJ) 109(10):750-755. https://doi.org/10.7196/SAMJ.2019.v109i10.12

Funder/Sponsors:
Principal Investigator Dr Ivana Beesham (MatCH), Prof Jenni Smit (MatCH), Dr Mags Beksinska (MatCH), Dr Mala Panday (DOH)
Site: MRU Durban
ECHO Trial (The Evidence for Contraceptive options and HIV Outcomes): A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)
ECHO Trial (The Evidence for Contraceptive options and HIV Outcomes):  A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

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This multicentre, open-label, randomised clinical trial sought to compare the risks of HIV acquisition between women randomised to Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) implant, and copper IUDs. The goal of the study was to answer the public health question of the relative risks (HIV acquisition) and benefits (pregnancy prevention) of three commonly-used, effective contraceptive methods among women who desired contraception. Approximately 7,800 sexually active, HIV-negative women not desiring to become pregnant, aged 16-35 years old, seeking effective contraception,  and willing to be randomised to any of the study arms,  were randomly allocated  to one of three study arms in a 1:1:1 ratio: DMPA, LNG, implant, copper IUD.  This study was conducted in 12 sites in Eastern and Southern Africa.   Enrolment  began in December 2015 and the study closed in October 2019, with a total of 7,830 participants completing between 12-18 months of follow-up.  

Data analysis was completed in June 2019 and results were publicly released at the 9th SA AIDS Conference in Durban South Africa and published in July 19. https://www.ncbi.nlm.nih.gov/pubmed/31204114

Key Findings:                                                                                                                                                       The ECHO Study found no substantial difference in the risk of getting HIV among 7 829 women randomly assigned to use one of three reversible, highly effective contraceptives:

  • DMPA-IM
  • copper IUDs
  • LNG implants

For more information on ECHO study visit: http://echo-consortium.com/

Funder/Sponsors: The Bill & Melinda Gates Foundation via FHI360, USAID,
Principal Investigator ECHO Consortium, Site Investigator Prof J Smit (MatCH Research)
Site: MatCH Research Commercial City and Edendale Research Site

echo study products

ECHO Ancillary Studies

Weight

This study is an ECHO ancillary study examining weight changes in women using three contraceptive methods: DMPA, Jadelle Implant and Copper IUD. In this study weight is measured at baseline and then 3 monthly for the duration of follow up in the main ECHO study. Weight gain is commonly cited as a side effect of hormonal contraceptives and is a frequent reason given for discontinuation. The quality of current evidence is considered low, due to a lack of randomization and high loss to follow-up or early discontinuation. This study will provide high quality evidence on the weight change debate and is ideally placed to examine weight change differences between the three methods, the effect of baseline BMI on future weight change and if early weight gain predicts further weight gain. It will also look at what leads to weight gain such as potential changes in appetite.

Contraceptive Method Discontinuation

During the ECHO study participants were randomised to one of 3 effective contraceptive methods i.e. the Copper IUD, the Jadelle implant and DMPA. At the final ECHO visit, participants were  given a choice of remaining on their contraceptive method or switching to another method. This study will look at reasons for contraceptive method discontinuation at the final ECHO visit; and retrospectively ascertain contraceptive method preferences at randomisation. In addition, participants were  contacted approximately 6 months after the ECHO study ends to find out if they had changed their contraceptive method since study exit and why.

What is reimbursement used for? Participant knowledge and perceptions of appropriate study reimbursement

The purpose of the reimbursement in research and clinical trials is to compensate participants for their time and transport costs. Although guidelines exist for reimbursement of trial participants (MRC, 2002; CIOMS, 1993; Belmont Report, 1979), acceptable reimbursement rates are under researched. Understandings of how participants allocate/spend their reimbursement money may be important to determine what an appropriate reimbursement amount is, or what factors contribute toward calculating appropriate reimbursement. This could be useful to ensure that reimbursement does not influence study participation in an adverse way and that it is fair and not undue.
Up to 500 women participating in the ECHO study will be invited to participate in a survey questionnaire exploring trends and influencing factors (such as income source, financial support from partners and marital status) to determine if any are significantly related. 2-6 focus group discussions will be held with participants to get a more detailed understanding of the perceived importance of reimbursement, how reimbursement money is spent, and attitudes towards reimbursement in research and clinical trials. This study will be conducted across Edendale and Commercial City Centre sites.

Pubic hair grooming practices: safety issues, association with STIs and vaginal cleansing.

Pubic hair grooming, defined as partial or full removal of pubic hair is gaining popularity globally and It is now a common practice among men and women. Recent studies have examined the relationship between demographic and behavioral risk factors associated with pubic hair grooming-related injuries with some finding ever having groomed was positively associated with a history of self-reported STIs.
There is limited information on pubic grooming (hair removal) practice in Africa. The study aims to investigate pubic hair grooming practices and the association with pubic hair grooming injuries, with STIs and with vaginal cleansing practices. Data collection is complete and analysis is underway.

Completed Studies

A health sector and community-based participatory approach in a human rights framework, to increase met needs for contraception: The UPTAKE Project
A health sector and community-based participatory approach in a human rights framework, to increase met needs for contraception: The UPTAKE Project

The UPTAKE Project is multi-country complex designed intervention using a community and health care provider participation approach in the provision of family planning and contraceptives. The study objective is to increase met needs for family planning/contraception, through the development, implementation and testing of an intervention involving community and health care provider participation within a human rights framework. The study is being conducted in Kenya, South Africa and Zambia. Formative work has been undertaken to understand perceptions of quality of care and barriers and enablers to accessing family planning methods and services. An intervention package is being developed and refined based on findings from the formative phase, using the theory of change model.

Funder/Sponsors: WHO (World Health Organisation)
Principal Investigator Prof J Smit (MatCH Research)
Site: MatCH Research (SA), KwaZulu Natal, eThekwini municipality
Collaborators: Zambia – University Teaching Hospital (PI – Theresa Nkole); Kenya – International Centre for Reproductive Health – Kenya (PI – Peter Gichangi)

 

The Quatro Study: Acceptability study of (placebo) vaginal delivery forms for preventing HIV and unintended pregnancy among young women in Zimbabwe and South Africa
The Quatro Study: Acceptability study of (placebo) vaginal delivery forms for preventing HIV and unintended pregnancy among young women in Zimbabwe and South Africa

Despite the crucial need, available products to prevent HIV infection and pregnancy, such as male condoms, female condoms, and microbicides, are not under women’s control and are inconsistently used, especially in low resource settings. The purpose of the Quatro study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or MPT delivery forms, using placebo products in 18-30 year old African women: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.

In addition, data collection activities will be designed to inform development of product educational messages tailored for young women in these Sub-Saharan African settings. The study was  conducted in Durban, South Africa and Harare, Zimbabwe and is currently in a dissemination phase.

 

Funder/Sponsor: United States Agency for International Development and The Bill & Melinda Gates Foundation via

CONRAD, Arlington, VA, United States and Women’s Global Health Imperative, RTI International, San Francisco, CA, United States

Investigators: WGHI, RTI International

Ariane van der Straten, Elizabeth Montgomery

Principal investigator

CONRAD

Jill Schwartz

MatCH Research Unit

Jenni Smit, Mags Beksinska

UZ-UCSF

Z Mike Chirenje, Nyaradzo Mgodi

Site: MRU Commercial City Clinic Site

Quatro