Family planning in couples with HIV

Principal Investigator: Susan Allen, M.D., M.P.H., DTM&H, Professor Global Health

Location:  Lusaka, Zambia

Funding Agency: National Institutes of Child Health and Development (NICHD)

ABSTRACT

Eighty percent of the world’s HIV infections are in sub-Saharan Africa. In Lusaka, the capital of Zambia, 85% of pregnant women are married and 47% are in couples with at least one HIV+ partner (26% concordant positive, 21% discordant). It will be years before short course antivirals are widely implemented and many children who escape infection will be left orphaned. There are 360,000 AIDS orphans in Zambia, a country of 9 million, and 35,000 HIV+ women deliver each year. Prevention of unplanned pregnancy in couples with HIV can reduce pediatric AIDS, HIV orphans, and the family consequences of parental illness and death.

We have previously HIV tested and counseled 10,000 couples from Lusaka for our ongoing NIH funded studies of heterosexual HIV transmission. In a pilot randomized controlled trial of family planning promotion with 251 couples, we observed a marked increase in injectable and oral hormonal contraceptive uptake. The attrition rate was high, however, and compliance with oral contraception was poor. Although incident pregnancy was lower with the intervention, the magnitude of the impact was far less than anticipated. Effective, user-independent methods such as the IUD and Norplant had lower attrition rates but they are unfamiliar to providers and clients and few women elected to use them.

In this study, we will enroll 5,000 concordant HIV+ and discordant couples in a randomized factorial trial of two interventions to reduce unplanned pregnancies. The first intervention will promote more effective contraception by placing user independent methods first in the educational message hierarchy and employing positive message framing. The second intervention will help couples plan for the consequences of their illness and death. This will include assisting husband and wife to work together and prepare a will, choose a guardian, and make a financial plan. By focusing on the cost of educating existing children and on the need to plan for their future care, we will encourage couples to reflect on the implications of future childbearing. We hypothesize that this will result in a decision to limit fertility. A standard family planning service will be compared with either or both interventions with respect to impact on incident pregnancy, contraceptive choice and pattern of use, psychosocial and behavioral variables, and future planning actions. Cost-effectiveness will be determined with methods developed jointly by experts in the fields of HIV therapy in Africa and contraception. 

SPECIFIC AIMS: The availability of inexpensive short-course antiviral regimens for prevention of intrapartum.

HIV transmission has galvanized the public health sector in Africa, where >90% of childbearing HIV infected women live. There is now consensus that voluntary HIV testing and counseling (VCT) is critical both for identification and treatment of HIV+ pregnant women and for prevention of heterosexual transmission in married couples. Our research team has provided same-day VCT to 10,000 couples in Lusaka, the capital of Zambia, and has transferred the same-day VCT technology to antenatal care clinics. ln Lusaka, over 25% of pregnant women are HIV+, >85% are married, and 45% are in couples with one (20%) or both (25%) partners infected with HIV. We are working with the district health authorities to establish couples’ VCT in Lusaka antenatal clinics and facilitate prevention of both perinatal and heterosexual HIV transmission.

Our goal now is to further leverage the impact of VCT by combining it with ‘family planning’ and thereby reduce 1) pediatric AIDS, 2) the number of children who would become AIDS orphans, and 3) the adverse family consequences of becoming ill or dying of HIV. Our first strategy is to increase the adoption of long acting, user-independent contraception by restructuring method hierarchy on the provider side and diminishing health risk concerns on the client side. Our second strategy is to focus on future planning for the consequences of HIV disease and in so doing enhance the motivation to limit fertility.

We have completed a pilot study of a randomized control trial of family planning promotion in couples from Lusaka. We have also conducted preliminary qualitative investigations relevant to fertility and contraception in Zambian couples. Bridge funds have been awarded by NICHD for analysis of these data and development of video-based interventions. This will allow recruitment for the proposed randomized control trial to begin soon after funds are awarded.

Aim 1: To conduct a randomized control trial of two interventions aimed at reduce fertility in 5,000 married Zambian concordant HIV+ and discordant couples followed for 1-4 years.

1. a) Hypothesis: Fertility among couples with one or both HIV+ partners can be reduced by >=20% with an intervention that places user-independent reversible methods at the top of the message hierarchy and targets health related fears and mistrust of these methods.

1. b) Hypothesis: Fertility among couples with one or both HIV+ partners can be reduced by >=20% with an intervention based on ‘future time perspective’ which assists couples with taking concrete steps to plan for their dependents in the event of their illness or death.

Aim 2:  To define patterns of contraceptive use including method selection, discontinuation, switching, intermittent use (‘resting’), dual barrier and non-barrier method use.

2. a) Hypotheses: IUD and Norplant will be selected more often by women who participate in the ‘user-independent’ method intervention. Selection of IUD and Norplant will be associated with less discontinuation and lower long-term pregnancy incidence than selection of injectable or oral contraception.  Injectable and oral contraceptive users in the methods intervention arm will have better adherence and fewer contraceptive failures than method users in the control arm.

2. b) Hypotheses: Women who participate in the ‘user-independent’ methods intervention will be less likely to discontinue method use and less likely to report side effects or health concerns as a reason for discontinuation.

Aim 3. To compare couples in the future time perspective intervention group with other study couples with respect to future planning actions.

3. a) Hypotheses: Couples who participate in the future time perspective intervention will be more likely to complete a formal will, select a guardian for their children, keep their children in school, and establish a financial plan for future schooling than couples who did not.

3. b) Hypotheses: Among couples who suffer a death of a partner, surviving family members of those who participated in the intervention will suffer fewer negative outcomes (eviction, property grabbing, children leaving school, debt) than family members of those who did not.

Aim 4. To assess the cost-effectiveness of the interventions

Hypothesis: The cost of adding the interventions to current services will be less than the costs averted from pediatric HIV infections prevented, orphan burden reduced, increased family resources mobilized for surviving children, and avoidance of maternal and paternal time and resources spent on an unplanned pregnancy and pediatric AIDS.

Aim 5: To compare the relevant psychosocial and behavioral variables that predict and mediate successful outcomes.

Hypothesis: Communication between husband and wife, concern about the prospects of being widowed or leaving orphans, and higher scores on future time perspective scales will be predictive of fewer incident pregnancies, more user-independent contraceptive use, and more future planning actions. These measures will increase after the future time perspective intervention.

PROGRESS REPORT FISCAL YEAR 4 (Final Year)

Studies and Results

The grant was awarded in July 2001. In FY one, due to the political situation in Zambia, with elections scheduled for the Fall and ultimately delayed until January 2002, we focused our efforts on preparatory activities including obtaining IRB approvals, developing and pilot testing intervention videos and one-on-one procedures, form development and testing, finalizing Teleform scannable databases, training medical staff to insert IUD’s and Norplant/implants in the research clinics, and enrolling 150 couples with one or both partners HIV+ into a pilot study. In FY 2-4, we have been enrolling and randomizing couples. Between July 02 and December 2004, we screened over 8,000 couples at our VCT centers. Of those, 3,538 had one or both partners HIV+: 1,389 of these couples were ineligible due to not having a pregnancy in the last 7 years (511), being currently pregnant (283), having cohabited < 12 months (281) being outside the age criteria (107), or having a contraindication to modern contraceptive use. Of 2,194 eligible couples, 1,552 (71%) have been enrolled  (1,017 concordant HIV+, 280 M-F+, and 255 M+F-), and 1,236 (80% of enrolled couples) have been randomized.  Of the 1,037 randomized couples with at least one follow-up visit, 258 were in the control group and viewed videos about hygiene and malaria prevention; 260 were in the motivational group and viewed a 35 minute video modeling desired ‘planning’ behaviors such as preparing a will and developing a financial plan for children’s schooling; 263 were in the methods group and viewed a 35 minute educational video  with a hierarchy of methods beginning with IUD and implant, followed by injectable contraception, and ending with OCP. The remaining 256 couples participated in both the motivational and methods interventions according to the factorial design of the study. All couples had previously been counseled about condom use on the day of CVCT, and were offered condoms consistently throughout the study.  

Fewer than 7% of 1,037 couples randomized did not select any contraceptive method after the video sessions. Couples who viewed the methods video were 3-4 times as likely to choose IUD than those who did not (6-8% vs. 2%). Selection of tubal ligation (2-3%), implant (9-15%), Depo-Provera (38-44%) and oral contraception (34-38%) was similar in all groups. Kaplan-Meier analysis showed a significantly lower pregnancy incidence in the intervention groups compared with the control group (log rank and Wilcoxon rank sum tests p<0.05, KM curve next page). Condom use in discordant couples did not differ among the different method users and non-users.

Couples in the intervention arms were more likely to report having acted on a plan to reallocate household income towards children’s education compared with the control arm (28-32% vs. 20%). Will preparation in the 3 months following randomization was 7 times more common among couples who saw either the motivational video (17%) or both videos (15%), and twice as common among couples who saw the methods video (4%) compared with the control couples (2%). Motivational viewers were also significantly more likely to name a guardian (20-25% vs. 9% of methods viewers and 6% of controls).

55 couples in whom a partner has died following randomization have been interviewed by a counselor to assess the social circumstances of the family following the death, and to assess the impact of having participated in the motivational intervention. 75 couples in whom a pregnancy has occurred have been interviewed about the reasons for, outcome of, and feelings about the pregnancy.

Significance

Our study has confirmed that behavioral video-based interventions can positively affect contraceptive initiation, pregnancy incidence, and planning activities in couples with one or both partners HIV+. The videos have now been implemented as standard of care in two couples’ VCT centers in the north of Zambia, and an application is pending with the PEPFAR program to expand our couples’ VCT center activities in Lusaka to allow inclusion of these videos and provision of long acting contraceptives once randomization for this study has ended.

Plans

We plan to continue enrollment until June 2004, to allow 9 months of follow-up in the last enrolled couple. Four abstracts have been submitted to the International AIDS Society meeting in Rio (July 2005).