Strategies to improve male partner involvement in microbicide research needed

Vaginal microbicides were partially developed in response to power differentials within sexual relationships and gender norms that make it difficult for women to negotiate other forms of HIV protection, as it can be used without the male partner’s knowledge, consent or compliance. However, evidence presented at the HIV Research for Prevention conference (R4P) held in Cape Town, South Africa in October suggests that microbicide trial participants usually choose to talk to steady partners about their product use and that male partners’ knowledge and acceptance of microbicide use promoted product acceptability and self-reported adherence to microbicide regimens among women.

Women in several microbicide trials also reported that involving their male partners in microbicide use benefited their relationships, including improving communication and relationship quality and increasing shared responsibility for HIV protection.

“Constructively engaging male partners in women-centered health programs such as family planning and PMTCT [prevention of mother-to-child transmission] has resulted in both improved health and relationship outcomes. Concerted efforts to engage men in women’s microbicide use for HIV prevention could make it easier for women to access and use microbicides, if an effective product is identified”, said Dr Elizabeth Montgomery from RTI International who conducted primary and secondary analyses of male engagement data from six qualitative studies implemented in conjunction with microbicide trials in South Africa, Kenya and Tanzania (MDP 301, Carraguard, VOICE, Adolescents and Microbicides Trials and IPM 014a, IPM 015, VivaGel). The analyses included 535 interviews and 107 focus groups with trial participants, male partners, and community members. The findings across the studies were synthesised and recommendations for future research and microbicide introduction were developed.

Glossary

microbicide

A product (such as a gel or cream) that is being tested in HIV prevention research. It could be applied topically to genital surfaces to prevent or reduce the transmission of HIV during sexual intercourse. Microbicides might also take other forms, including films, suppositories, and slow-releasing sponges or vaginal rings.

disclosure

In HIV, refers to the act of telling another person that you have HIV. Many people find this term stigmatising as it suggests information which is normally kept secret. The terms ‘telling’ or ‘sharing’ are more neutral.

focus group

A group of individuals selected and assembled by researchers to discuss and comment on a topic, based on their personal experience. A researcher asks questions and facilitates interaction between the participants.

qualitative

Qualitative research is used to explore and understand people’s beliefs, experiences, attitudes or behaviours. It asks questions about how and why. Qualitative research might ask questions about why people find it hard to use HIV prevention methods. It wouldn’t ask how many people use them or collect data in the form of numbers. Qualitative research methods include interviews, focus groups and participant observation.

open-label

A clinical trial where both the researcher and participants know who is taking the experimental treatment. 

The analyses found that women used different strategies to gain partner approval, such as using the product for a while before telling their partner, giving their partner information about trial participation or microbicides gradually or continuing to bring up microbicides in conversation.

Among men who were aware of their partner’s microbicide use, involvement ranged from opposition to agreement or non-interference to active support. Both men and women expressed a desire for men to have access to information about microbicides. Some of the men and women stated that it would be helpful if male partners could talk with a health provider about microbicides, but men were often hesitant to go to the clinic during the trials because of their work schedules, fear of HIV testing, and stigma.

The effect of men on the participation of women in microbicide research was illustrated in the VOICE-D study presented at the conference. Thirty per cent (n = 139) of sensitised and pre-screened presumptively eligible women in Uganda stated that their reason for never attending trial sessions was because they had no income and feared losing financial support from their male partners. The women who missed initial screening visits stated this was due to their male partners’ refusal or fear of their reaction.

Partner disclosure in microbicide research

In-depth interviews (n = 63) and focus groups (n = 8) were held with CAPRISA 008 participants about disclosure of microbicide use and study participation, as well as the male partners of 13 women who fully disclosed trial participation and gel use. Four focus groups were held with community men who were not partners of CAPRISA 008 participants.

CAPRISA 008 is an ongoing open-label follow-on trial of 1% tenofovir gel of HIV-negative CAPRISA 004 trial participants.

Most (n = 53 of 63) of the CAPRISA 008 participants interviewed told their partner at least some details about being in the trial or use of the gel. Ten participants did not disclose any information about study participation, 16 partially disclosed (either disclosed they were participating in a study or that they were using a gel and that the purpose of the study was HIV prevention), while 37 women disclosed all of the above and that the gel contains an ARV (antiretroviral).

Women disclosing gel use to a partner perceived it easier to adhere to the regimen, while the male partners of these women described feelings of initial fear and apprehension of the gel, followed by gradual acceptance after being more fully informed.

Motivating factors for disclosure included perceived difficulty in hiding gel from a partner and a desire to inform others about the benefits of the gel. However, women who did not disclose also described the ease of hiding gel use from their partners. Barriers to disclosure included fear that the partner would not understand her motivations for using the gel for HIV prevention or that he would react negatively to her use of an intravaginal product.

Men who were not partners of study participants revealed in focus groups that disclosure was indicative of the quality and seriousness of a relationship: women in casual relationships could use gel without disclosing while those in stable relationships should discuss gel use because non- disclosure inferred lack of trust. These men also felt that counsellors and pharmacists could assist women in explaining the purpose and use of the gel to their partner.

Increasing male involvement in microbicide use

Dr Montgomery recommended that healthcare providers should counsel women to support them to decide whether and how to talk with their partners and support their right to decide whether to talk with their partners, including strategies for gaining partner’s agreement or using it without his knowledge. Further recommendations were that men’s awareness and acceptance can be increased through couples counselling, community education in spaces where men congregate by providing general information on the benefits and safety of microbicides and mass media messaging.

Some of these strategies have already been implemented to enhance male involvement in the Study to Prevent Infection with a Ring for Extended Use (ASPIRE/MTN 020) trial, an HIV prevention study investigating the use of an intravaginal dapivirine ring. These strategies include couples counselling and HIV testing, offering facilitated trial participation disclosure sessions with men, hosting male health education weekend workshops and inviting male partners to study-retention events. These activities included information on contraception, sexually transmitted infections and HIV, in addition to information about the purpose and objectives of the study, research misconceptions and the importance of partner support.

The ASPIRE trial, a multi-center, randomised, double-blind, placebo-controlled phase 3 trial conducted at sites in Malawi, South Africa, Uganda and Zimbabwe, enrolled 2629 sexually active women between the ages of 18 and 45 years, who were using contraception.

The participants’ permission to contact their partners was secured verbally by an allocated community healthcare worker. The extent of disclosure (regarding study participation and/or ring use) was then documented. Male partners were contacted telephonically with regard to their willingness and availability to attend. All information was documented and updated prior to male involvement events and used to plan event agendas and to ensure that the partner’s attendance does not lead to disclosure beyond what has already been disclosed by the study participant to their partner.

Male partner attendance at events was minimal due to work-related reasons. Participant feedback revealed that approximately 50% of participants have disclosed study participation to partners with a favourable response in most cases. Partners also appear supportive in terms of reminding participants of visits and product adherence.

References:

Montgomery E et al. Engaging Male Partners in Women’s Microbicide Use: Evidence from Clinical Trials and Implications for Future Research and Microbicide Introduction. HIV Research for Prevention Conference (HIV R4P), abstract OA02.01, Cape Town, South Africa, 2014.

Reddy Ket al.Strategies to Improve Male Involvement and Partner Support in the ASPIRE Trial: The Hillbrow Experience. HIV Research for Prevention Conference (HIV R4P), abstract OA02.02, Cape Town, South Africa, 2014.

MacQueen Ket al. Gel Use Disclosure in an Open-label 1% Tenofovir Gel Trial: Perspectives from Participants, Partners and Community Men in KwaZulu-Natal, South Africa. HIV Research for Prevention Conference (HIV R4P), abstract OA02.03, Cape Town, South Africa, 2014.

To view the slides and listen to the audio of these presentations, go to: Oral Abstract Session 02: Microbicides: Male Partner Engagement and Sexual Behaviors at http://webcasts.hivr4p.org

Nakyanzi Tet al.Why Women at High Risk for HIV-1 Infection Did Not Join the VOICE Study in Uganda: A Qualitative Community Study. HIV Research for Prevention Conference (HIV R4P), abstract OA09.01, Cape Town, South Africa, 2014.

To view the slides and listen to the audio of these presentations, go to: http://webcasts.hivr4p.org/console/player/25056?mediaType=audio&

All conference abstracts are available at: http://hivr4p.org/abstracts-and-conference-materials

Dayton R et al. Engaging male partners in women’s microbicide use: Evidence and Recommendations. Family Health International (FHI 360), 2014.

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